MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SHAFT PILOT 6MM; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	53-4106
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Breakage.It was reported that during the hip replacement operation,when did the "proximal reaming", breakage occurred at the threaded junction of the distal guide rod and the conical reamer.It is not known whether there are metal debris in the fracture site remained in the patient.Another device was used to complete the operation.The operation delayed about 40 mins.The patient was stable and left from hospital now.
Additional Manufacturer Narrative
Product complaint #: (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.

• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10523388
• Report Number: 1818910-2020-19906
• Device Sequence Number: 3118726
• Product Code: LXH
• UDI-Device Identifier: 10603295171713
• UDI-Public: 10603295171713
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2020

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: 53-4106
• Device Catalogue Number: 534106
• Device Lot Number: SO2012274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 09/22/2020; 04/22/2021
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 09/22/2020; 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1