MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS BROACH SZ 8; HIP INSTRUMENTS : BROACHES

Catalog Number 201203080

Device Problems Break (1069); Crack (1135); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

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 Description

It was reported that the size 08 trilock broach was inserted via kincise impactor.Surgeon noted an unfamiliar feeling after impaction.X-ray was taken and identified a fracture at the distal tip of broach.Surgical delay of one hour.

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.Removed patient harm insufficient information.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Email received with additional event information clarifying that the broach did not fracture.The femur of the patient was fractured during impaction.This is what caused the delay.The impactor did not present any failure.

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.H10 additional narrative:  added d1, d2(common name, procode) and d4(catalog, udi).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: a review of the provided x-ray confirmed the femoral fracture.There has been no allegation against the braoch.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.

• Brand Name: TRI-LOCK BPS BROACH SZ 8
• Type of Device: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10464973
• MDR Text Key: 206119016
• Report Number: 1818910-2020-18973
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201203080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 95