MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR +4 NEUT 480DX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221832448
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
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
It was reported that the screw tip of liner trial broke off during surgery.No surgical delay.
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.Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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.Territory 230 reports that the screw tip of liner trial broke off during surgery.No surgical delay.Examination of the returned trial liner confirmed that the c-clip and screw components disassembled from the trial shell and were not returned.A search of the complaint database found the user over-tightening the threaded insert during use and intentionally disassembling the snap ring from the screw for surgical preference or cleaning are suspected root causes.A health hazard evaluation (b)(4) was conducted in november of 2011.The investigation did not establish the need for corrective action based on no immediate patient risk, the low frequency of reported events, and suspected customer misuse as the root cause.No evidence was found of product or design error as a contributing factor.Complaints will be monitored under post market surveillance sep 419.

• Brand Name: PIN TRL LNR +4 NEUT 480DX32ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9221238
• Report Number: 1818910-2019-111263
• Device Sequence Number: 2183487
• Product Code: LXH
• UDI-Device Identifier: 10603295101017
• UDI-Public: 10603295101017
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/01/2019

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: 221832448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/30/2019; 11/21/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/22/2019; 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR