MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM ASSEM UPPER PULL ROD; RECLAIM INSTRUMENTS : INSERTION DEVICES

Catalog Number 297500635

Device Problem Device Damaged by Another Device (2915)

Patient Problem Not Applicable (3189)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Component would not engage in the distal stem.On inspection, the thread of this pull rod was found to be slightly burred / damaged.

Manufacturer Narrative

Investigation summary: the device was reviewed by depuy melbourne and confirmed the damage to the threads.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

• Brand Name: RECLAIM ASSEM UPPER PULL ROD
• Type of Device: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8030408
• MDR Text Key: 125863442
• Report Number: 1818910-2018-74239
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295156017
• UDI-Public: 10603295156017
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 297500635
• Device Lot Number: SO2021781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 11/22/2018
• Supplement Dates FDA Received: 11/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2016
• 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: 83 YR