MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP STEP IM REAMER; KNEE INSTRUMENT : REAMERS

Model Number 9505-02-079

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

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 these are broken instrument out of office sets.No surgery affected.Dull.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device reveals wear form normal use and servicing.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.

• Brand Name: HP STEP IM REAMER
• Type of Device: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10462467
• MDR Text Key: 205580446
• Report Number: 1818910-2020-18949
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295227908
• UDI-Public: 10603295227908
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

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 Model Number: 9505-02-079
• Device Catalogue Number: 950502079
• Device Lot Number: NG0508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2020
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1