MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CONV FB PS TB TRL SZ4; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Catalog Number	254500974
Medical Device Problem Codes	Break (1069); Crack (1135); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.Investigation summary: examination of the returned device confirms the reported event.Depuy 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.The complaint consisted of (b)(4) attune conv fb ps tb trl sz4, lot number bfa0ndk.Examination of the returned device confirmed the reported crack.The trial was fractured diagonally across one condyle running adjacent to the larger balseal.A chip was broken off and missing where the crack meets the edge of the trial.No damages to the balseals themselves were noted.A complaint database search on the provided product code family identified similar complaints.This type of damage to trial is consistent with using a device in a prying motion to disassemble the mating instruments after trialing.This issue has been captured in a capa and determined the likely root cause to be related to misuse.Based on the root cause determination related to misuse, a need for corrective action is not indicated but will be monitored.Depuy 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.
Event or Problem Description
Upon routine inspection in spd it was noted that two of the size 4 articulating shims were cracked.The ballseal springs are still in tact and this issue was not noticed in surgery.No adverse effects were reported.Engineering evaluation: examination of the returned device confirmed the reported crack.The trial was fractured diagonally across one condyle running adjacent to the larger balseal.A chip was broken off and missing where the crack meets the edge of the trial.No damages to the balseals themselves were noted.
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.Depuy 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.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.

• Brand Name: ATTUNE CONV FB PS TB TRL SZ4
• Common Device Name: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8422088
• Report Number: 1818910-2019-87337
• Device Sequence Number: 2249459
• Product Code: JWH
• UDI-Device Identifier: 10603295135517
• UDI-Public: 10603295135517
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 02/22/2019

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: 254500974
• Device Lot Number: BFA0NDK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1