MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SHAFT PILOT 16X11; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	534151
Medical Device Problem Codes	Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
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
It was reported that the shaft pilot (p/n: 534151) was come off when using a cone reamer because the mode switch had been set to reverse rotation during the tha surgery on (b)(6) 2019, and the shaft pilot was remained in medullary cavity.Although the surgeon attempted to remove the shaft pilot from medullary cavity, it could not.Thus, the surgeon made another incision on the knee, put k-wire into the incision, pushed the shaft pilot from distal side, and removed it from proximal side.The surgery was completed within a 30 minutes surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9267737
• Report Number: 1818910-2019-113653
• Device Sequence Number: 16248171
• Product Code: LXH
• UDI-Device Identifier: 10603295171744
• UDI-Public: 10603295171744
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 534151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 01/03/2020; 01/03/2020
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 01/03/2020; 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR