MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM ASSEMB TOOL ADAPT 85MM; RECLAIM INSTRUMENTS : INSERTION DEVICES

Catalog Number	297500610
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2013
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.Investigation summary: examination of the returned component found the spring to be deformed and broken out of instrument.The root cause is attributed to design.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.
Event or Problem Description
Bal seal has been damaged.Damaged bal seals are being returned.The assembly tool body is not being returned, as the bal seals have been replaced.They have been replaced with bal seals x574850 as per drawing attached to this product complaint form.This case has been reported by the loan kit technician during loan kit inspection.It has been forwarded to depuy engineering for assessment.No further information can be obtained as the case was not reported by the customer.

• Brand Name: RECLAIM ASSEMB TOOL ADAPT 85MM
• Common Device Name: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9279377
• Report Number: 1818910-2019-114120
• Device Sequence Number: 2812124
• Product Code: LXH
• UDI-Device Identifier: 10603295155966
• UDI-Public: 10603295155966
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2013

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 Catalogue Number: 297500610
• Device Lot Number: SO0000351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1