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

Model Number	9620-06-000
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
End of pin retained in patient during surgery, noted in xray.
Additional 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1818910-2020-08463
• Device Sequence Number: 16747977
• Product Code: KWA
• UDI-Device Identifier: 10603295240549
• UDI-Public: 10603295240549
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 9620-06-000
• Device Catalogue Number: 962004000
• Device Lot Number: 988065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/24/2020; 05/26/2020; 06/01/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 03/30/2020; 05/27/2020; 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1