MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE SPACER BLOCK; ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS

Catalog Number 254401014

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

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

During a total hip replacement the cup impactor was having difficulty threading onto the pinnacle cup implant.The impactor was replaced and surgery continued.During the 6.5 screw insertion into the acetabulum the hex screwdriver broke apart inside the patient.All pieces were retrieved: two washers hex head, hex shaft and locking bolt.One of the washers was lost during decontamination.No surgical delay no patient consequences.Later during an inspection of instrumentation an attune spacer block was found with a chip off one of the bearing surfaces and a rotating platform sz4 articulating surface was found with a crack on the underside.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device was received hence the failure mode cannot be confirmed.The root cause is undetermined.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.

Manufacturer Narrative

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

• Brand Name: ATTUNE SPACER BLOCK
• Type of Device: ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8201135
• MDR Text Key: 131585890
• Report Number: 1818910-2018-79304
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295395379
• UDI-Public: 10603295395379
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2018

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: 254401014
• Device Lot Number: BFA10A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 02/05/2019; 02/15/2019
• Supplement Dates FDA Received: 02/06/2019; 03/16/2019
• Patient Sequence Number: 1