MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP PS ARTIC SURF SZ6; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number 2545-00-546

Device Problem Material Integrity Problem (2978)

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

Event Date 08/18/2021

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 a bag of instruments were given by the sterile processing department that had been damaged.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was received for examination.After physical review of the part, it was observed an articulated surface device with a broken balseal.Post along with spring was chipped away from the rest of the part.Also device presents several denotes several usage wear deformations and scratches.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: 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE RP PS ARTIC SURF SZ6
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12918802
• MDR Text Key: 283781058
• Report Number: 1818910-2021-26996
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295132868
• UDI-Public: 10603295132868
• 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,Followup
• Report Date: 08/18/2021

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: 2545-00-546
• Device Catalogue Number: 254500546
• Device Lot Number: MVMBSW580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2014
• 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