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

Model Number 9505-01-230

Device Problem Material Deformation (2976)

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

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

The above hospital have the following device which has bent in use.Tibial jig spiked up rod ref 950501230 lot number a0308 reported today.Surgery not delayed no adverse effects for patient.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: HP EM TIBIAL JIG SPIKED UPROD
• 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 dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward av; west chester, PA 19380 ; 6107428552
• MDR Report Key: 13112054
• MDR Text Key: 284904952
• Report Number: 1818910-2021-28964
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295225355
• UDI-Public: 10603295225355
• 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,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 9505-01-230
• Device Catalogue Number: 950501230
• Device Lot Number: A0308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2008
• 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