MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION SYSTEM HANDLE; HANDLES

Model Number 2546-00-100

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(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 2nd stage knee revision the surgeon reported fracturing the proximal tibia when seating the the attune revision tibial broach in the proximal tibia.The surgeon had already prepared the proximal tibia bone with a stem pilot/broach and tib tray however when he extracted the trial construct (with rp adapter and system handle) the tib tray rotation was not locked and therefore he was required to re-seat the stem trial/broach into the prepared bone envelope and lock off his rp tray rotation before extracting and transferring this to the definitive implant/assembling.He commented that when the registrar re-inserted the broach into the bone she hit it too hard which he thinks caused the fracture.It was worth noting that the registrar also had great difficulty extracting the trial stem and broach/tray construct once the rotation had been locked and when the surgeon took over, he ended up removing the rp trial tray and attaching the broach handle to remove the broach (which is when he noticed the small fracture in the prox tib) and repeating the above steps to set the rotation.The surgery continued as planned and he advised that this fracture would not change the outcome of the surgery.He did comment that the rp adapter which clicks on to the system handle is designed poorly as he thinks it spins around too easily and wobbles a lot when trying to engage the rp tibial trial tray for extraction.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6 (device).No code available (3191) is used to capture customer feedback/dissatisfaction.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added d4(lot#), d10 and h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned device found no defect.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE REVISION SYSTEM HANDLE
• Type of Device: HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10521855
• MDR Text Key: 206533557
• Report Number: 1818910-2020-19867
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295438731
• UDI-Public: 10603295438731
• 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,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2546-00-100
• Device Catalogue Number: 254600100
• Device Lot Number: AB4291710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention