MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB PS ARTIC SURF SZ4; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500504
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the upper and lower shims were separated when the surgeon explanted the trial insert (p/n: (b)(4)) during tka surgery on (b)(6) 2019, and the ring came off and remained in the patient's body.The surgeon retrieved the ring from the patient and completed the surgery within a 30 minutes delay.There was no adverse consequence to the patient.It was requested to improve such as integrated insert trial creation.No further information is available.
Additional 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.
Additional Manufacturer Narrative
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.Product complaint #: (b)(4).Investigation summary: examination of the returned device confirms the reported event of a damaged balseal on the smaller post of the trial.Hhe (health hazard evaluation)/qrb (quality review board) 103045639 recommended a device correction which was initiated on june 12, 2015.Capa-004795 determined the likely root cause to be related to misuse, and requires mandatory sales training on proper use and application of the device by depuy sales consultants.Capa-004795 will also monitor the mandatory field training.The need for further corrective action was not indicated.Continue to monitor per post market surveillance sep-419.Device history lot: null.Device history batch: null.Device history review: null.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.
Additional Manufacturer Narrative
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: corrected: d10.Product complaint # : (b)(4).Investigation summary = > examination of the returned device confirms the reported event of a damaged balseal on the smaller post of the trial.Hhe (health hazard evaluation)/qrb (quality review board) 103045639 recommended a device correction which was initiated on (b)(6), 2015.Capa(b)(4) determined the likely root cause to be related to misuse, and requires mandatory sales training on proper use and application of the device by depuy sales consultants.Capa-004795 will also monitor the mandatory field training.The need for further corrective action was not indicated.Continue to monitor per post market surveillance sep-419.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: ATTUNE FB PS ARTIC SURF SZ4
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8552319
• Report Number: 1818910-2019-91689
• Device Sequence Number: 16233306
• Product Code: JWH
• UDI-Device Identifier: 10603295135517
• UDI-Public: 10603295135517
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 254500504
• Device Lot Number: MVMBSY780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 06/07/2019; 07/01/2019; 07/01/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/20/2019; 07/01/2019; 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1