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

Catalog Number	950502089
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
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
During pkr surgery a threaded headed pin product number listed above was used to secure a cutting jig to the femoral condyle, during the insertion of the pin with a powered driver, the pinhead sheered off, leaving the distal threaded portion of the pin remaining in the condyle.The surgeon was aware of the pin shearing off and handed the proximal portion of the pin to the scrub nurse.This was then disposed of in a sharps container as per hospital policy.The action was taken: identification of the proximal pin, followed by an examination of the pin site.Patient recovering as expected.There was no delay to the procedure, the surgery continued as planned with a different pin being used.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.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.A review of complaint databases was not possible as no product details were received.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 HEADED 6 PK
• Common Device Name: KNEE INSTRUMENT : FIXATION PINS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9296906
• Report Number: 1818910-2019-115249
• Device Sequence Number: 11356167
• Product Code: LXH
• UDI-Device Identifier: 10603295227922
• UDI-Public: 10603295227922
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 10/15/2019

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: 950502089
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR