MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*CONE REAMER,12B-1N; HIP INSTRUMENTS : REAMERS

Model Number 53-4700

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 04/09/2020

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

The primary surgery was performed on (b)(6) 2020 via tha.During the surgery, when the surgeon connected the reamer (p/n: 534700) to the shaft (p/n: 534107) and reamed bone-marrow cavity, the shaft came off from the reamer and remained in the bone cavity.The surgeon removed the shaft with a long pean forceps under x-ray.After that, when the surgeon reamed proximal bone because he had difficulty in reducing in the trialing, the shaft came off from the reamer again and remained in the body.The second time, it took time to remove the shaft because the shaft came off at deep point of the bone-marrow cavity despite the nurse tighten the reamer and the shaft.The surgery was completed within 30 minutes delay.It was possible that the patient was inversion position when the surgeon reamed.After the surgery, when the surgeon checked the devices, he could not insert the shaft into the reamer for appropriately depth (some soft tissue or bone chips might adhere the shaft or the reamer because the devices were before cleaning.).The devices had no problem when the hospital checked before the surgery.No further information is available.

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.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 : the products were returned and the reported issue confirmed.The root cause was deemed to be unintended user error.Depuy 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.

• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9991372
• MDR Text Key: 188719568
• Report Number: 1818910-2020-11210
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295172031
• UDI-Public: 10603295172031
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53-4700
• Device Catalogue Number: 534700
• Device Lot Number: MT1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1