MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*REAMER PROXIML FEM 14B; HIP INSTRUMENTS : REAMERS

Catalog Number	534702
Medical Device Problem Codes	Break (1069); Fitting Problem (2183)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/02/2019
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.(b)(4).
Event or Problem Description
It was reported that the shaft pilot was come off from the cone reamer (p/n: 534702) when the surgeon took the instruments out from medullary cavity during the tha surgery which was combined with osteotomy surgery on (b)(6) 2019 and the shaft pilot was remained in medullary cavity.It was difficult to remove the shaft pilot, and it was removed by performing osteotomy first.The surgeon considered it had not been connected properly and attempted using it again after reattached them however the same issue occurred.The surgery was completed within a 30 minutes surgical delay.Dr¿s view: it was able to remove the shaft pilot after the osteotomy, but it may have been difficult to remove if it occurred during normal surgery.There was a possibility of it was happened because it might be easily detached due to deterioration over time of the joint part.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9240443
• Report Number: 1818910-2019-112193
• Device Sequence Number: 19243943
• Product Code: HTO
• UDI-Device Identifier: 10603295172055
• UDI-Public: 10603295172055
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 534702
• Device Lot Number: MT43833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 12/29/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 12/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR