MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV TIB CEM CONICAL RMR; ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS

Model Number 2506-20-103

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

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

There was an attune tkr case done in meh 28/11, with the following implants used: the preparation of primary knee instruments was done accordingly and as per planned.Femur cuts proceeded as per normal, when proceeding to tibia preparation, dr asked for short cemented tibia 14x50mm stem and we got the instruments ready.He drilled for the stem, then attach the stem trial to the fat reamer (for the cone).Just when he was about to do the keel punch, the instrument fell onto the ground.He then checked with dr who decided to prepare the keel as per primary tray.Upon preparing as per primary tray, he followed through the trial with the primary tray trial construct and decided on the implants to be used.Despite not trialling with the stem, dr asked for the stem implant and decided to implant with it as the preparation was already made.While cementing and implanting the tibia, he experienced some resistance and managed to impact and implant the tibia with stem successfully.Upon closure, our reps cleared the instruments which were all left in the basin by the ot scrub nurse and realised the stem trial which was originally tightly screwed onto the fat conical reamer was missing and alerted dr.Dr called for an xray and then realised the stem trial was in the tibia canal.

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: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.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.

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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.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 REV TIB CEM CONICAL RMR
• Type of Device: ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9491271
• MDR Text Key: 188077204
• Report Number: 1818910-2019-123922
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295440567
• UDI-Public: 10603295440567
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2019

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 Model Number: 2506-20-103
• Device Catalogue Number: 250620103
• Device Lot Number: NG64604
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 02/03/2020; 02/10/2020
• Supplement Dates FDA Received: 02/07/2020; 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1