MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS BROACH SZ 6; HIP INSTRUMENTS : BROACHES

Model Number	2012-03-060
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon tried to attach the broach of size 6, the broach could not be attached to the handle.The surgeon had no choice but to use a broach of size 7 but failed to achieve proper reduction.Therefore, the surgeon used a broach with a size of 5 to ream the calcar deeply and implanted a real implant of size 6, which appeared to be successful in reduction.The surgery was completed successfully with 20 minutes delay.The broach in question could not be attached to a summit universal broach handle either which was prepared as a spare instrument.The surgeon commented that the handle joint of the broach of size 6 was deformed.No further information is available.
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.
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 when the surgeon tried to attach the broach of size 6, the broach could not be attached to the handle.The surgeon had no choice but to use a broach of size 7 but failed to achieve proper reduction.Therefore, the surgeon used a broach with a size of 5 to ream the calcar deeply and implanted a real implant of size 6, which appeared to be successful in reduction.The surgery was completed successfully with 20 minutes delay.The broach in question could not be attached to a summit universal broach handle either which was prepared as a spare instrument.The surgeon commented that the handle joint of the broach of size 6 was deformed.No further information is available.
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).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 device cannot confirm the reported allegation.A functional test was performed and the device assembles and disassembles as intended.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: TRI-LOCK BPS BROACH SZ 6
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13524159
• Report Number: 1818910-2022-02800
• Device Sequence Number: 5299531
• Product Code: HTQ
• UDI-Device Identifier: 10603295082118
• UDI-Public: 10603295082118
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/14/2022

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: 2012-03-060
• Device Catalogue Number: 201203060
• Device Lot Number: PG244536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 02/17/2022; 03/29/2022; 04/14/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 02/23/2022; 03/30/2022; 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 46 KG