MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIG HP REV TORQ LMT SCRWDRVR; KNEE INSTRUMENT : TORQUE DEVICES

Model Number 2011-03-080

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

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

It was reported that the handle attachment is loose.

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 confirms the reported event.The investigation did not establish that a broader investigation or corrective action was necessary.Depuy 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 dhr for p/n 201103080, lot number km876434 was reviewed and no anomalies were found.Parts were produced and shipped accordingly with no rework or defects f corrected: h3.

• Brand Name: SIG HP REV TORQ LMT SCRWDRVR
• Type of Device: KNEE INSTRUMENT : TORQUE DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12135762
• MDR Text Key: 262880364
• Report Number: 1818910-2021-14704
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295436379
• UDI-Public: 10603295436379
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2021

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: 2011-03-080
• Device Catalogue Number: 201103080
• Device Lot Number: KM876434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 08/02/2021; 10/11/2021
• Supplement Dates FDA Received: 08/06/2021; 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1