MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK BROACH

Catalog Number UNK BROACH

Device Problems Device-Device Incompatibility (2919); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2018

Event Type  malfunction  

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

"literature article entitled, ¿washing the femoral canal results in more predictable seating of a short, tapered femoral stem¿ by abdallah husseini, et al; published by the journal of arthroplasty (2018), vol.33, pp.3220-3225, was reviewed.The purpose of this study was to compare the incidence of a trilock bone preservation stem implant size mismatch after femoral rasping in washed vs unwashed femoral canals in 170 patients.The authors determined the mismatch when a stem ¿sat proud¿ more than 2 mm after rasping the femoral canal.The mismatch was corrected by adjusting the offset length of the femoral head.Results: 60 cases of implant mismatch of 2 or more mm.The authors determined the incidence of mismatch was greater when the femoral canal was not irrigated after femoral rasping.The authors attributed the mismatch to the rasp itself and the bone debris created with the diamond shaped cutting surface of the rasp.There were no patient consequences noted nor were there any deficiencies of the stem reported.All procedures were completed by adjusting the offset of the femoral head to achieve limb asymmetry.Captured in this complaint: hip instrument: broach (rasp).Pec: functional: trial does not replicate implant.Symptoms code: no signs symptoms, or patient involvement.Health impact code: no patient consequences".

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device associated with this report was not returned.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.Corrected: h6 (medical device problem code).

• Brand Name: UNK BROACH
• Type of Device: BROACH
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10940888
• MDR Text Key: 243691823
• Report Number: 1818910-2020-26065
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK BROACH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1