MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BROACH SZ8; HIP INSTRUMENTS : BROACHES

Catalog Number	257000150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
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 broken instrumentation requiring osteotomy.Patient was brought to the operating room for a left anterior total hip replacement.During the procedure, there was malfunction of the depuy femoral trial broach (fracture of the broach) which required osteomy of the femur for the removal of the trial broach.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrections: h1, h6 patient h6 patient: femoral osteotomy resulting in a surgical delay of 2 hours.Report was initially submitted on 10/9/2019 but the third acknowledgment was not received until 10/18/2019.The correction information, stated above, was identified on (b)(6) 2019 but was unable to be sent via follow-up medwatch submission due to the delay of the third acknowledgment until this time.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: product complaint (b)(4).Investigation summary:the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT BROACH SZ8
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9209054
• Report Number: 1818910-2019-108771
• Device Sequence Number: 305844
• Product Code: JDI
• UDI-Device Identifier: 10603295142959
• UDI-Public: 10603295142959
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/16/2019

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: 257000150
• Device Lot Number: J0405
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 09/17/2019; 11/05/2019; 11/07/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 10/22/2019; 11/06/2019; 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 91