MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE IMPACTION HANDLE; KNEE INSTRUMENT/TRIAL

Catalog Number 254401017

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/12/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

During the inspection of the attune returned loan kit, the orthokit; technician noted that the trigger of the attune impaction handle was broken.No patient harm reported.

Manufacturer Narrative

This complaint remains in investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

Conclusion and justification status: conclusion and justification status: the complaint states - the attune impactor was broken in 2 pieces, - the trigger of the attune impaction handle was broken.The investigation confirmed that the lever had broken on the impaction handle and the impactor were broken as reported.It should be noted that a field safety notice was issued stating that to reduce the possibility of leaving fragments in patients to adhere to the ifu which include inspecting the instruments to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure with regard to both the impactor and impaction handle.Expert opinion indicates that the failures are associated with environmental stress cracking (esc).The attune fb tibial impactor has been annealed to reduce residual stresses.Lab tests indicate significant reduction in residual stresses of annealed samples in comparison to un-annealed samples however a complete reduction in stresses is not achievable.This device is from an annealed batch.The complaint shall be closed to capa and product design; it will be entered into the complaint database and monitored through trend analysis.Depuy still 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.

• Brand Name: ATTUNE IMPACTION HANDLE
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5144102
• MDR Text Key: 28033759
• Report Number: 1818910-2015-32562
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup
• Report Date: 10/27/2015

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 Catalogue Number: 254401017
• Device Lot Number: NW152956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2014
• 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