MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN BOSS-STM ADPTR XTRCTR; ADAPTORS

Catalog Number 254600404

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 01/29/2019

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.

Event Description

It was reported that the attune revision 29mm sleeve broach got stuck in the tibia.Both broach handle kept releasing on extraction.The small end of the extractor rod was inserted into the broach and a crossbar was put through that to extract the sleeve.Trying to get the rod out of the broach and the tip broke off inside.The 37mm broach was inserted next and it got stuck also.Both broach handles kept releasing.With the extraction rod broken the surgeon screwed the trial rp base plate onto the broach.Tried extracting the whole construct with the system handle and the box adapter.The system handle kept releasing also.It eventually was able to be worked out with this construct.

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.Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the reported event of device breakage.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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: ATUN BOSS-STM ADPTR XTRCTR
• Type of Device: ADAPTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8349618
• MDR Text Key: 136511845
• Report Number: 1818910-2019-84931
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295492023
• UDI-Public: 10603295492023
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

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: 254600404
• Device Lot Number: GM47608NE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1