MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK REAMER

Catalog Number UNK REAMER

Device Problems Break (1069); Entrapment of Device (1212); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 05/29/2019

Event Type  malfunction  

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.

Event Description

Medical records received.After review of medical records, it was indicated that during the revision surgery, while reaming, the reamer disengaged from the flexible shaft and a bit of the reamer broke off.The surgeon attempted to retrieve the reamer bit but was unsuccessful even with c-arm fluoroscopic guidance.The surgeon elected to leave the reamer bit in place.Doe: (b)(6) 2019 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Information has been reviewed and determined that this product complaint cannot be verified to have been manufactured and/or distributed by depuy synthes.Therefore, there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a depuy device after it was released for distribution.There is no report of an adverse event involving a depuy device.If additional information is received regarding product it will be evaluated at that time.

• Brand Name: UNK REAMER
• Type of Device: REAMER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9878605
• MDR Text Key: 190816162
• Report Number: 1818910-2020-09200
• Device Sequence Number: 1
• Product Code: HTO
• 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
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK REAMER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR