MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MTO STNDRD ACETBLR REAMR 44MM; HIP INSTRUMENTS : REAMERS

Catalog Number 299956334

Device Problems Dull, Blunt (2407); Failure to Cut (2587); Illegible Information (4050)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

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

It was reported that the reamers are dull and numbers were faded.No surgical delay.

Manufacturer Narrative

H10 additional narrative: product complaint #
=
> pc-(b)(4).Investigation summary
=
> examination of the returned instrument confirmed the complaint.Depuy-synthes 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MTO STNDRD ACETBLR REAMR 44MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10075927
• MDR Text Key: 191602958
• Report Number: 1818910-2020-12365
• Device Sequence Number: 1
• Product Code: LXH
• 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: 05/05/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 299956334
• Device Lot Number: PS0209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 05/27/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1