MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS BROACH SZ 4; HIP INSTRUMENTS : BROACHES

Model Number	2012-03-040
Medical Device Problem Codes	Break (1069); Scratched Material (3020)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
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 when attempting to remove the sz 4 broach after trialing, the retaining pin on the top of the broach broke.The surgery was extended in order to perform an osteotomy to retrieve the broach from the proximal femur with multiple vice grips and a slap hammer.The proximal femur required 1 ortho cable.All pieces were removed from the wound and likely the broach was fatigued.Surgical delay of 25-30 minutes.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.Depuy-synthes 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.Patient code: no code available (3191) was used to capture surgery prolonged, surgery, and insufficient information.

• Brand Name: TRI-LOCK BPS BROACH SZ 4
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10097849
• Report Number: 1818910-2020-12785
• Device Sequence Number: 3540399
• Product Code: HTQ
• UDI-Device Identifier: 10603295082095
• UDI-Public: 10603295082095
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2012-03-040
• Device Catalogue Number: 201203040
• Device Lot Number: PG0308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 06/09/2020; 06/24/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 06/11/2020; 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR