MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS BROACH SZ 3; HIP INSTRUMENTS : BROACHES

Model Number	2012-03-030
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
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
It was reported that the surgeon broached up to a 3 broach and implanted a size 3 thrilock std.It sat proud and after rebroaching it still sat proud.He then removed the stem and broached up to a 4 then implanted a new size 3.This delayed the case about 5-10 minutes but was not detrimental to the outcome.I will wash and return the implant in question.Doe: (b)(6) 2020.Affected site: unknown.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > the instrument associated with this report was not returned.The root cause could not be determined.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.H10 additional narrative: added: h6 (patient codes) h6 patient code: no code available (3191) used to capture the prolonged surgery and insufficient information.

• Brand Name: TRI-LOCK BPS BROACH SZ 3
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10097527
• Report Number: 1818910-2020-12768
• Device Sequence Number: 19717746
• Product Code: HTQ
• UDI-Device Identifier: 10603295082088
• UDI-Public: 10603295082088
• 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): 05/12/2020

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 Model Number: 2012-03-030
• Device Catalogue Number: 201203030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRI-LOCK BPS BROACH SZ 3; TRI-LOCK BPS SZ 3 STD OFFSET; TRI-LOCK BPS BROACH SZ 3; TRI-LOCK BPS SZ 3 STD OFFSET