MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DRLC SCR TRL LN LIP 32ID 70OD; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	223870000
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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 58 +4n trial liner is broken.It is a duraloc, so very old.Threaded part is missing from liner trial.The case was a 52 cup and this is a 58 so there was no issue in the case.This was brought to sales reps attention.It had no delay to the case.
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: brand name, common device name, device identification and concomitant medical products.Corrected: device evaluated by mfr.Investigation summary: examination of the returned instrument confirmed the reported observation and also found some scratches and nicks on the trial.The root cause is attributed to inadvertent use error and wear out.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 242 reported that the 58 +4n trial liner is broken.It is a duraloc, so very old.Threaded part is missing from liner trial.The case was a 52 cup and this is a 58 so there was no issue in the case.This was brought to sales reps attention.It had no delay to the case.Examination of the returned trial liner confirmed that the snap ring and screw components are broken out.The screw component was returned.Visual examination also found some scratches and nicks on the trial from misuse and heavy usage.The complaint consisted of (1) 223870000 drlc scr trl ln lip 32id 70od, lot number unknown.The lot number required to determine date of manufacture was not known.A search of the complaint database against instruments in the same family found the user over-tightening or cross-threading the threaded insert during use and intentionally disassembling the snap ring from the screw for surgical preference or cleaning are suspected root causes.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under sep 419 post market surveillance.Device history lot: null.Device history batch: null.Device history review: null.

• Brand Name: DRLC SCR TRL LN LIP 32ID 70OD
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9147296
• Report Number: 1818910-2019-107354
• Device Sequence Number: 2652708
• Product Code: LXH
• UDI-Device Identifier: 10603295108085
• UDI-Public: 10603295108085
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 09/11/2019

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: 223870000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1