MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE 0 DEG RIGHT CUT BLOCK; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number 2544-00-015

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> the device associated with this report was returned for investigation.Examination of the returned device can confirm the complaint.Depuy syntheses 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.Examination of the returned device can confirm the reported event.Visual examination can see in the groove of the saw capture is deformed, the deformed condition occurred by cutting into by a saw blade.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 during a routine inspection of some attune consignment instrumentation trays, by sterile processing department personnel, it was discovered that three of the instruments were damaged.Two attune femoral impactor were cracked and the saw capture of a tibial cutting guide had been cut into by a saw blade.Both cracks extended from the central portion to distal portion of the two impactors.The cut in the tibial cutting guide in located in the lateral edge of saw capture.Replacement instruments are needed to complete the consignment trays.

• Brand Name: ATTUNE 0 DEG RIGHT CUT BLOCK
• Type of Device: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14208577
• MDR Text Key: 290089952
• Report Number: 1818910-2022-07552
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295421191
• UDI-Public: 10603295421191
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-00-015
• Device Catalogue Number: 254400015
• Device Lot Number: PG225487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2013
• 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