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

Model Number 96-6110

Device Problems Device-Device Incompatibility (2919); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The noted damage is consistent with device use from normal use and servicing and the investigation did not establish a need for corrective action.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.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).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 locking mechanism of the sp*2 femoral locating device is no longer locking.

Manufacturer Narrative

Product complaint # :(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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:  added d10 corrected h3 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported event.The noted damage is consistent with device use from normal use and servicing and the investigation did not establish a need for corrective action.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.The complaint sample consisted of (1) 966110 sp*2 femoral locating device.The date code jo501 indicates this device was manufactured in may 2001.Examination of the submitted femoral locating device identified that the spring component (90000b10-45) is missing resulting in malfunction of the locking mechanism.The overall condition of the device indicates heavy usage over time.A complaint database search found similar reported events against product code 966110.Previous reported events attributed similar events to device wear from normal use and servicing.Although no conclusion could be drawn about the root cause of missing spring component, product wear out is suspected based on the age (mfg 2001) and overall condition of the instrument.Based on the root cause determination of unknown, the need for corrective action was not indicated.Monitor complaints through (b)(4).Depuy synthes 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9475474
• MDR Text Key: 175498457
• Report Number: 1818910-2019-123204
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295246831
• UDI-Public: 10603295246831
• 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,Followup
• Report Date: 11/25/2019

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
• Device Operator: Health Professional
• Device Model Number: 96-6110
• Device Catalogue Number: 966110
• Device Lot Number: JO501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/10/2019; 01/16/2020; 02/12/2020
• Supplement Dates FDA Received: 01/02/2020; 01/17/2020; 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR