MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SPACER BLOCK; ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS

Model Number 2544-01-014

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2021

Event Type  malfunction  

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

It was reported that on (b)(6) 2021, the patient underwent bilateral tka surgery for knee osteoarthritis with attune system.After completing the procedure for the right knee, they found that a round shaped spring of the attune spacer block in question was missing.The surgeon confirmed by intraoperative x-rays that the spring was not in the patient¿s body.Then, the surgeon started procedures for the left knee and completed the surgery.The surgery and the anesthesia time were delayed by about 15 minutes due to the intraoperative x-rays.After the surgery, they searched for the spring, but they could not find it.It is not clear whether the spring had come off from the device before the surgery or it come off during the surgery.The patient is now in the hospital and under follow-up.No further information is available.

Manufacturer Narrative

Product complaint #
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>(b)(4) investigation summary
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> the device associated with this report was not returned for evaluation, but photograph review was able to confirm the reported event.The investigation did not establish that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot
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> 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.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device associated with this report was not returned for evaluation, but photograph review was able to confirm the reported event.The investigation did not establish that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.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.,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.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE SPACER BLOCK
• Type of Device: ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11552634
• MDR Text Key: 241879386
• Report Number: 1818910-2021-05785
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295395379
• UDI-Public: 10603295395379
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/04/2021

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: 2544-01-014
• Device Catalogue Number: 254401014
• Device Lot Number: BFA1JJL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 07/01/2021; 08/06/2021; 09/03/2021
• Supplement Dates FDA Received: 07/01/2021; 08/16/2021; 09/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 70