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

Catalog Number 534702

Device Problems Break (1069); Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 10/02/2019

Event Type  Injury  

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 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.

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.

• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward av; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9240443
• MDR Text Key: 174224312
• Report Number: 1818910-2019-112193
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295172055
• UDI-Public: 10603295172055
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR