MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR NEUT +4 40ID 58OD; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221840458
Medical Device Problem Codes	Break (1069); Component Missing (2306); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
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 trial 58 +4 neutral liner is missing the thread in portion to attach to cup.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > examination of the returned instrument confirmed the reported observation.The root cause is attributed to inadvertent use error.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).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.  additional narrative:   added: description of event or problem and concomitant medical products.Corrected: device evaluated by mfr and device identification the lot code (pg0308) is being retracted since it was incorrectly submitted in the initial medwatch.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
Additional information received that the instrument was used in surgery.There was no surgical delay.

• Brand Name: PIN TRL LNR NEUT +4 40ID 58OD
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9371841
• Report Number: 1818910-2019-117929
• Device Sequence Number: 2902360
• Product Code: LXH
• UDI-Device Identifier: 10603295101536
• UDI-Public: 10603295101536
• Combination Product (Y/N): N
• 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): 10/29/2019

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: 221840458
• Device Lot Number: PG0308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 11/02/2019; 12/23/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 11/27/2019; 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1