MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV TIB TRIAL EXTRACTOR; EXTRACTION INSTRUMENTS

Model Number	2546-00-401
Medical Device Problem Codes	Device Slipped (1584); Device-Device Incompatibility (2919); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
During a 2nd stage knee revision the surgeon reported fracturing the proximal tibia when seating 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.
Additional 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: a1 and h6 (device).No code available (3191) is used to capture customer feedcak/dissatisfaction.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional 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.
Additional 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.
Additional 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 REV TIB TRIAL EXTRACTOR
• Common Device Name: EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10521867
• Report Number: 1818910-2020-19868
• Device Sequence Number: 19612502
• Product Code: HWB
• UDI-Device Identifier: 10603295438700
• UDI-Public: 10603295438700
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2546-00-401
• Device Catalogue Number: 254600401
• Device Lot Number: AB4568519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 09/13/2020; 11/09/2020; 11/10/2020; 11/10/2020; 04/19/2021
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 09/17/2020; 11/10/2020; 11/24/2020; 11/27/2020; 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention