MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE IM ROD; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Model Number 2544-00-502

Device Problems Break (1069); Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/01/2020

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

Has product been potentially contaminated or is contaminated with bodily fluids? yes 2545-00-928 has a crack that was discovered during cleaning/steam sterilization.2545-01-969 has broken into 2 pieces that happened per-op.2544-00-502 a piece of plastic fell off during use per-operative.Where / when did the event occur? intra - op, post - op.What action was taken/required to manage the problem during the procedure? with same like product.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported event.No evidence was found indicating product malfunction or product error as a contributing factor to the damage and the need for corrective action was not indicated.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.

• Brand Name: ATTUNE IM ROD
• Type of Device: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10541471
• MDR Text Key: 207172267
• Report Number: 1818910-2020-20222
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295130024
• UDI-Public: 10603295130024
• 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
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-00-502
• Device Catalogue Number: 254400502
• Device Lot Number: ABG50392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1