MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PIN PULLER; ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number 2545-00-060

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

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.

Event Description

Attune pin puller in loan set not latching onto attune pinning system.Surgeon able to still pull pins out throughout case with tool but reported handle was slightly loose.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: after examination of the returned photos the failure mode could not be confirmed.Root cause undetermined.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.

• Brand Name: ATTUNE PIN PULLER
• Type of Device: ATTUNE INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10360003
• MDR Text Key: 201550069
• Report Number: 1818910-2020-17413
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295130574
• UDI-Public: 10603295130574
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

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
• Device Operator: Health Professional
• Device Model Number: 2545-00-060
• Device Catalogue Number: 254500060
• Device Lot Number: PG246438
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1