MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP THREADED PINS 6 PK; KNEE INSTRUMENT : FIXATION PINS

Catalog Number	950502088
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During the surgery one of the pins (hp quick drill pins, 950502072 or hp threaded pins, 950502088) snapped and broke in the sigma hp power pin driver (9505-02-071).This remained in the pin driver and therefore the pin driver could not be used during the remainder of the case.As a result, please do not charge the hospital for one missing a pin or the pin driver damage as this happen during use.I am unaware of which kit the missing pin and damage to the pin driver occurred, therefore please can this be noted on both bookings.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.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.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).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).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.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) 2018 - pi re-open: device received in (b)(4).Examination of the returned pins could not identify the reported fracture.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HP THREADED PINS 6 PK
• Common Device Name: KNEE INSTRUMENT : FIXATION PINS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7682755
• Report Number: 1818910-2018-64321
• Device Sequence Number: 1370178
• Product Code: LXH
• UDI-Device Identifier: 10603295227915
• UDI-Public: 10603295227915
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/20/2018

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 Catalogue Number: 950502088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/31/2018; 10/16/2018; 12/07/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 09/03/2018; 10/19/2018; 12/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1