MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV CEM STEM TRL14X50; ATTUNE STEMMABLE TIBIA INSTRUMENTS : STEM TRIALS

Model Number	2512-14-050
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 will be filed as appropriate.

• Brand Name: ATTUNE REV CEM STEM TRL14X50
• Common Device Name: ATTUNE STEMMABLE TIBIA INSTRUMENTS : STEM TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9491253
• Report Number: 1818910-2019-123924
• Device Sequence Number: 2086267
• Product Code: LXH
• UDI-Device Identifier: 10603295477808
• UDI-Public: 10603295477808
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 2512-14-050
• Device Catalogue Number: 251214050
• Device Lot Number: NW194110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 02/03/2020; 02/10/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/07/2020; 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1