MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE ADJ TIB STYLUS; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Model Number 2544-00-007

Device Problem Crack (1135)

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

Event Type  malfunction  

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

It was reported that tibial stylus had cracked when resetting trays.Did not impact any case.

Manufacturer Narrative

Product complaint # :(b)(4).Investigation summary
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> examination of the returned device found that the red overmold handle on the stylus was broken.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.Device history lot
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> the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.H10 additional narrative:  added: d9 corrected: h3.

• Brand Name: ATTUNE ADJ TIB STYLUS
• Type of Device: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11020530
• MDR Text Key: 221792695
• Report Number: 1818910-2020-27072
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295129790
• UDI-Public: 10603295129790
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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: 2544-00-007
• Device Catalogue Number: 254400007
• Device Lot Number: NW130636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2020
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1