MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM TRIAL SZ 7 RT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Model Number 2545-00-707

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Date 08/12/2020

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

Navigated attune cr rp tkr; surgeon was drilling femoral lugs through size 7 r cr trial with attune lug drill.Drill got stuck in femoral trial to the extent that when the lug drill was removed from femur, it pulled the femoral trial off which was stuck to the lug drill.Tapped the trial off the drill, and the bushing from the femoral trial was retained on the lug drill, could not be removed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device and review of the provided photos revealed the metal bushing component of the trial was damaged and separated from the trial.The noted damage is consistent with product wear out resulting in unintentional product damage.The investigation did not establish a need for corrective action.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Corrected: e1 (reporter name and country code) and h3.

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.Patient code: no code available (3191) is used to capture prolonged surgery and insufficient information.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CR FEM TRIAL SZ 7 RT
• Type of Device: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10459905
• MDR Text Key: 204554124
• Report Number: 1818910-2020-18879
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295133797
• UDI-Public: 10603295133797
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-00-707
• Device Catalogue Number: 254500707
• Device Lot Number: MVMBSC190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1