MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 CHARN PIN RETRACT+HANLESET; HIP INSTRUMENTS : FIXATION PINS

Model Number 9620-06-000

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.

Event Description

End of pin retained in patient during surgery, noted in xray.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative:  product complaint (b)(4).Investigation summary :no product was received from the complainant.However we did receive a report from a third party with photographs which confirmed the reported issue.From the information provided it appears that the charnley pin was put under a high bending force which led to the snapping of the retractor pin, although from the information provided, it was not possible to verify this and determine the root cause.The pin was 23 years old and as the pin had been used at least 38 times since (b)(6) 2018, it is unlikely that the break was due to a manufacturing error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative:   added: b5, h6 (device).

Event Description

In addition to the previously reported product deficiency, the medical record indicates the pin broke into 2+ pieces intra-operatively and retained in the patient.There is no evidence of revision or invasive treatment to address the issue.

Manufacturer Narrative

Product complaint# (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative:  added: d4 (lot).Corrected: d4 (procode,udi).

• Brand Name: CHARN PIN RETRACT+HANLESET
• Type of Device: HIP INSTRUMENTS : FIXATION PINS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9848554
• MDR Text Key: 186144557
• Report Number: 1818910-2020-08463
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295240549
• UDI-Public: 10603295240549
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9620-06-000
• Device Catalogue Number: 962004000
• Device Lot Number: 988065
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 03/24/2020; 05/26/2020; 06/01/2020
• Supplement Dates FDA Received: 03/30/2020; 05/27/2020; 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1