MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S3 15.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number 962033

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

Event Type  malfunction  

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.

Event Description

It was reported that the opened sterile packing was discovered a hair wrapped around keel of insert.Surgeon was not upset and has forgotten about it nor was hospital upset.

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.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.H10 additional narrative: product complaint (b)(4).Investigation summary : the complaint sample consisted of (1) 962033 pfc sigmarp cv tb/in s3 15.0.The reported event was assigned to the manufacturing site depuy cork for investigation/evaluation.Depuy cork reports:a visual review was conducted on the returned sample.The packaging was not returned in its original state; the outer blister and outer tyvek lid were not present.The inner pouch was completely opened, and the part was loose in the carton.There was no hair visible on the part or in the returned packaging.At the time of review, the sample met visual requirements outlined in tm-101629 and pic-101461.There was no evidence to support allegation of ¿hair wrapped around keel of insert.Dhr review product code 962033, work order 8702670 (pfc sigmarp cv tb/in s3 15.0) was manufactured on 17 january 2018.18 parts were manufactured per specification and all raw materials met specification.1 part was scrapped out from lot 8702670 (a211: scratches) this is normal processing scrap and has no correlation with the failure mode.Parts are packaged as per sws- 0011 (sws for poly value stream sigma inserts, rp's and all poly pattelae clean room operation, rev.25) and pic-101461 (packaging inspection standards, rev.13) nr-0093803 is associated with this lot however there is no correlation with the failure mode.Nr0093803 is associated with a surface finish issue identified in march 2018.The complaint has been deemed unconfirmed.Based on this and the occurrence rating it was concluded that no further escalation was required.Dra-010327 was opened opened to assess the occurrences of this failure mode in the cork site and determine if any further action is required.Conclusion of the dra is as follows; ¿therefore there is no instances of ¿hair¿ identified within the non-conformance database within the depuy synthes facility.100% inspection of all packaged material is completed per value stream as per pic-101461 rev 13 and have been identified to be meeting requirements see note manufacturing investigation (b)(4).(updated) for the full details of depuy cork's investigation.The complaint has been deemed unconfirmed.Complaint trends will be monitored by post market surveillance through sep-419.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.

• Brand Name: PFC SIGMARP CV TB/IN S3 15.0
• Type of Device: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8568686
• MDR Text Key: 143684503
• Report Number: 1818910-2019-92107
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295240761
• UDI-Public: 10603295240761
• 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
• Report Date: 04/05/2019

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 Catalogue Number: 962033
• Device Lot Number: 8702670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 05/09/2019; 07/16/2019
• Supplement Dates FDA Received: 05/21/2019; 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR