MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM MILLER SHELL SZ 23; HIP INSTRUMENTS : INSERTION DEVICES

Model Number	2576-05-023
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Visual analysis found instrument product info etchings were damaged due to heavy nicks/scratching and wear throughout the complaint sample consistent with heavy usage.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.
Event or Problem Description
It was reported that srom instruments are difficult or impossible to read the sizing.Surgeon is concerned this is a patient safety issue and instruments should be replaced.No surgical delay.

• Brand Name: SROM MILLER SHELL SZ 23
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9900570
• Report Number: 1818910-2020-09631
• Device Sequence Number: 16850999
• Product Code: HWT
• UDI-Device Identifier: 10603295145554
• UDI-Public: 10603295145554
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: 2576-05-023
• Device Catalogue Number: 257605023
• Device Lot Number: AG0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR