MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 HP THREADED PINS HEADED 6 PK; KNEE INSTRUMENT : FIXATION PINS

Catalog Number	950502089
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that the surgeon was driving the pin into the tc3 size 4 cutting block and through the augment the pin bent and got bound up breaking the pin head off into the pin driver and bending the pin at the same time.
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
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: the complaint sample consisted of (1) 950502071 hp power pin driver, (1) 950502089 hp threaded pin headed, (1) 201103023 sig hp rev distal spacer 12mm and (1) 201103003 sig hp rev 4in1 cut blk sz4.Device history lot: null.Device history batch: null.Device history review: null.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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8425436
• Report Number: 1818910-2019-87455
• Device Sequence Number: 2170536
• Product Code: LXH
• UDI-Device Identifier: 10603295227922
• UDI-Public: 10603295227922
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019; 04/05/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/04/2019; 04/09/2019
• Patient Sequence Number: 1