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

Catalog Number	221832448
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/16/2019
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
While trialing a hip construct on the right side of the patient dr.Remarked that the trial 48/32 +4 neutral liner was moving inside the pinnacle sector ii sz 48 shell that had been implanted despite having screwed in the trial liner.Dr.Dislocated the hip construct leaving the 5 hi summit broach in the patient and handing over the summit 5 hi trial neck and 32 +1 articuleze trial head to the scrub tech.Dr.Removed the out broken piece with a kocher and then used a duraloc screwdriver handle and cardan screwdriver to remove the second piece of the broken trial liner.Rep then went downstairs to retrieve a second high performance pinnacle trial liner tray.The case was delayed 5 minutes while rep retrieved another tray of trial.All pieces were recovered.
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 : the instrument associated with this report was not returned.The attached photograph confirmed the instrument was broken.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.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 +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: 8855197
• Report Number: 1818910-2019-99875
• Device Sequence Number: 19308902
• Product Code: LXH
• UDI-Device Identifier: 10603295101017
• UDI-Public: 10603295101017
• 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): 07/16/2019

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?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1