MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 BIPOLAR HEAD ASSEMBLY TOOL HIP INSTRUMENTS : MISC

Catalog Number 855762000

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that it was found the screw of the head assembly tool. The head assembly tool had no screw when incoming inspection.

Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BIPOLAR HEAD ASSEMBLY TOOL
• Type of Device: HIP INSTRUMENTS : MISC
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8581937
• MDR Text Key: 144262706
• Report Number: 1818910-2019-92526
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 855762000
• Device Lot Number: SM6154809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown