MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR 10D 50ODX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Model Number	2218-32-150
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981); Scratched Material (3020)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Additional information indicated that the washer on the back of the liner trial broke off.It break into two or more pieces.
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
Found the liner trial broken.He notified dr.(b)(6) immediately of the broken trial.He met with the family and they decided ,they wanted the piece taken out.At the end of his day after 5 cases, he brought this patient back to surgery for the removal.The surgery time for the revision was 88 minutes.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision depuy synthes 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: examination of the returned instrument cannot confirm the complaint.Depuy-synthes 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.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PIN TRL LNR 10D 50ODX32ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9643984
• Report Number: 1818910-2020-03482
• Device Sequence Number: 13944414
• Product Code: LXH
• UDI-Device Identifier: 10603295100829
• UDI-Public: 10603295100829
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2218-32-150
• Device Catalogue Number: 221832150
• Device Lot Number: PG0910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/05/2020; 03/06/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/28/2020; 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention