MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 SIGMA HP DIS FEM RESECT GUIDE; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number 950501235

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2018

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 surgeon could not adjust amount of bone cutting because the adjustable knob was stiff during tka surgery on (b)(6) 2018.The surgery was finished without any other problem although it was not reported how the surgery was completed.There was no adverse consequence to the patient.No further information was provided by the hospital.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes warsaw for evaluation.A photograph of reported device was included with the investigation for review.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA HP DIS FEM RESECT GUIDE
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7726598
• MDR Text Key: 115244411
• Report Number: 1818910-2018-65364
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295225409
• UDI-Public: 10603295225409
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

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 Catalogue Number: 950501235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1