MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BROACH SZ6; HIP INSTRUMENTS : BROACHES

Model Number	2570-00-120
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
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 male connection part on the summit size 6 broach broke during surgeon use.The broken tip was no longer than 10mm and was found inside the broach handle.All parts were held together to ensure there were not any remaining pieces.Was verified by surgeon.
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).Investigation summary : the instrument associated with this report was not returned.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.Territory (b)(4) reported that the male connection part on the summit size 6 broach broke during surgeon use.The broken tip was no longer than 10mm and was found inside the broach handle.All parts were held together to ensure there were not any remaining pieces.Was verified by surgeon.The device associated with this report was not returned for evaluation.Attempts to get additional information went unanswered.The lot number that helps determine the age of the device was not available.Review of the device history records and/or a lot specific complaint database search was not possible as the lot code required was not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Complaints will be monitored under post market surveillance sep (b)(4).Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: SUMMIT BROACH SZ6
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11968382
• Report Number: 1818910-2021-12242
• Device Sequence Number: 14263432
• Product Code: HTQ
• UDI-Device Identifier: 10603295142935
• UDI-Public: 10603295142935
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 2570-00-120
• Device Catalogue Number: 257000120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR