MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 FEMORAL LOCATING DEVICE; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	966110
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Product name: sigma knee cutting block.Product code: 96-6110.Event: device cannot be moved to the right or left.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected:h6(device codes).Product complaint (b)(4).Investigation summary : the product was returned for investigation and the complainants comments were confirmed in that the central section of the instrument could not be moved to its full extent in both left and right directions.Visual inspection of the instrument showed that the ratchet mechanism used to move the central section left and right in increments had been repeatedly hit with a hammer / mallet.This had resulted in the peening over of material of the teeth of the ratchet mechanism and thus destroying the shape of the teeth and preventing the central section to move to its full extent.The complaint was confirmed and the root cause was wear and tear.The product shall be retained for future reference.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9295815
• Report Number: 1818910-2019-115192
• Device Sequence Number: 2334826
• Product Code: JWH
• UDI-Device Identifier: 10603295246831
• UDI-Public: 10603295246831
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 966110
• Device Lot Number: D0298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 01/09/2020
• Patient Sequence Number: 1