MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM REAMER BLUNT 12MM STR; HIP INSTRUMENTS : REAMERS

Catalog Number 536812

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.The root cause is attributed to use error.Depuy 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.Territory (b)(6) reports that multiple srom reamers were damaged during a surgery with surgeon.The reamers were used to "ream" through some hardware left in a hip.Since the reamers were used to do this, many of them have been damaged and need to be replaced.No further information is available at this time.Examination of the returned reamer confirmed the complaint; the flutes on the reamer are nicked with some areas missing material.The root cause is attributed to use error.Provided information states the reamers were used to "ream" through some hardware left in a hip.Since the reamers were used to do this, many of them have been damaged and need to be replaced.Reamers are not intended to ream through metal hardware, it's intended purpose is to ream bone.The complaint sample consisted of (1) 536812 srom reamer blunt 12mm straight, date code bm1298.The date code indicates the instrument was manufactured in december of 1998.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that multiple srom reamers were damaged during a surgery with surgeon.The reamers were used to "ream" through some hardware left in a hip.Since the reamers were used to do this, many of them have been damaged and need to be replaced.No further information is available at this time.No surgical delay.

• Brand Name: SROM REAMER BLUNT 12MM STR
• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8831292
• MDR Text Key: 176515451
• Report Number: 1818910-2019-99349
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295172963
• UDI-Public: 10603295172963
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 536812
• Device Lot Number: BM1298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/1998
• 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