MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HP EM TIBIAL JIG ANKLE CLAMP; KNEE INSTRUMENT : ALIGNMENT DEVICES

Model Number 9505-01-229

Device Problem Device-Device Incompatibility (2919)

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

Event Date 04/06/2022

Event Type  malfunction  

Event Description

It was reported that during a case the team at the hospital were unable to remove the tibial jig parts from the sigma hp kit.There was a surgical delay of five minutes.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> the device associated with this report was returned for analysis.Photographic evidence was reviewed.Visual examination of the device cannot confirm the complaint.Unable to disassemble allegation cannot be confirmed without the mating device for a functional test.However, examination found that the inner shaft button is jammed, it cannot be pressed down.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.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).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: HP EM TIBIAL JIG ANKLE CLAMP
• Type of Device: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14194136
• MDR Text Key: 289978293
• Report Number: 1818910-2022-07434
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295225348
• UDI-Public: 10603295225348
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9505-01-229
• Device Catalogue Number: 950501229
• Device Lot Number: NW130510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1