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

Model Number	2975-00-600
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the reclaim assembly tool for placing 2000 psi got stuck in implant after the tensile bar appropriately broke.Had to take out entire construct.Surgical delay of one hour reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).Retracting the reported lot number (d4) and manufacturing date (h4) in the initial medwatch.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6 (device).Re-captured device code.Removed the code for break.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > examination of the returned instrument confirmed the complaint.Depuy-synthes 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.

• Brand Name: RECLAIM ASSEM UPPER PULL ROD
• Common Device Name: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10470873
• Report Number: 1818910-2020-19034
• Device Sequence Number: 19635542
• Product Code: HWB
• UDI-Device Identifier: 10603295155942
• UDI-Public: 10603295155942
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2975-00-600
• Device Catalogue Number: 297500635
• Device Lot Number: SO2003032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/01/2020; 09/21/2020; 09/30/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/09/2020; 09/24/2020; 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RECLAIM ASSEMB TOOL ADAPT 75MM; RECLAIM PRX BDY CONE 20X75
• Patient Age: 69 YR