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

Model Number 2544-00-512

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problems Bruise/Contusion (1754); No Consequences Or Impact To Patient (2199); Injury (2348)

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 as the surgeon has been harmed when the handle slipped off the rod during insertion.

Event Description

Additional information received stating that it did not occur in theatre, sawbones activity.Parts are intact, no damage to instruments.Surgeon palm got injured.Just the handle and short rod and no serious surgeon injury just the awareness that it could happen.

Manufacturer Narrative

Product complaint #
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> (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 the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE BALANCED IM ROD HANDLE
• Type of Device: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10581674
• MDR Text Key: 208383070
• Report Number: 1818910-2020-20860
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295130116
• UDI-Public: 10603295130116
• 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
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-00-512
• Device Catalogue Number: 254400512
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1