FDA Adverse Event Malfunction Summary report: N

DXTEND GLENOSPHERE STD D38MM

MDR report key: 5264658 · Received December 3, 2015

Report

Report Number: 1818910-2015-32655
Event Type: Malfunction
Date Received: December 3, 2015
Date of Event: June 11, 2014
Report Date: June 11, 2014
Manufacturer: DEPUY ORTHOPAEDICS, INC. 1818910
Product Code: KWS
PMA / PMN Number: PK120174
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EXAMINATION OF THE RETURNED PRODUCT BY A DEPUY FRANCE SUPPLIER CONFIRMED THE COMPLAINT. THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR; FOUND DETERIORATION OF PRODUCTS DURING THE ASSEMBLY. A DEPUY FRANCE SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS AND FOUND THE PRODUCTS CONFORMED TO THE REQUIRED SPECIFICATIONS AND FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. (B)(4).

Description of Event or Problem · 1

WHEN INSERTING THE PRODUCT, THE SURGEON COULD NOT GET THE THREADS TO ENGAGE WITH THE BASEPLATE. AFTER NUMEROUS TRIES WITH THE NEW GUIDE WIRES AS INSTRUCTED IN THE SURGICAL TECHNIQUE, A NEW MATCHING PRODUCT WAS OPENED AND INSERTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
793284	DXTEND GLENOSPHERE STD D38MM	SHOULDER HEAD/GLENOSPHERE	KWS	DEPUY ORTHOPAEDICS, INC. 1818910		5228436

Patients

Seq	Age	Sex	Outcome	Treatment
1