MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE IMPACTION HANDLE; ATTUNE INSTRUMENTS : HANDLES

Catalog Number 254401017

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.Investigation summary: examination of the returned device confirmed the reported breakage.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.Review of the returned device confirmed that the attune impaction handle had a broken lever.All the pieces were not returned.Provided information stated the broken piece was discarded and no pieces were left in the patient.The root cause for this failure mode has been investigated as part of (b)(4) and determined to be "incorrect geometry and material selection for load application".See the capa for more information related to the investigation.The risk associated with this failure mode has been assessed and determined an occurrence score of "l1" for each potential harm identified (the product problem has never been known to result in the identified harm, and it is not reasonable to expect that it ever would).The complaint does not indicate any patient effect or surgical delay.This is consistent with the findings of the hhe and previous complaint investigations.The qrb recommended field correction in the form of a communication to device users.Further corrective action has been identified and information can be found under a capa.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.

Event Description

Impactor handle broke during surgery, the release lever broke into two pieces.All items retrieved from patient, loose piece was discarded.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Corrected: device evaluated by mfr.Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported breakage.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE IMPACTION HANDLE
• Type of Device: ATTUNE INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8445047
• MDR Text Key: 139612934
• Report Number: 1818910-2019-88226
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295423324
• UDI-Public: 10603295423324
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• 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: NW142523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR