MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TRL BLT SZ 3-5 POR; ATTUNE CEMENTLESS INSTRUMENTS : TIBIAL KEEL PUNCH/BULLET

Catalog Number	254500184
Medical Device Problem Codes	Break (1069); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon didn¿t conical team before using impaction tip and wing of the bullet broke off.No patient impact.
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
Product complaint # (b)(4).Investigation summary: surgeon didn¿t conical team before using impaction tip and wing of the bullet broke off.No patient impact.Tray has been marked as having a broken instrument in and will return with the loan set.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed the attune rp trl blt sz 3-5 por was broken.The broken fragment was returned for evaluation.The investigation was able to confirm the reported event.No other problem identified.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces and failure to follow the instructions mentioned in the ifu by using device in off label manner.The overall complaint was confirmed as the observed condition of the attune rp trl blt sz 3-5 por would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended user error.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photographs revealed that the proximal portion of the tibial punch has broken off.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photographs revealed that the proximal portion of the tibial punch has broken off.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE RP TRL BLT SZ 3-5 POR
• Common Device Name: ATTUNE CEMENTLESS INSTRUMENTS : TIBIAL KEEL PUNCH/BULLET
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17378470
• Report Number: 1818910-2023-14960
• Device Sequence Number: 12337840
• Product Code: LRY
• UDI-Device Identifier: 10603295419891
• UDI-Public: 10603295419891
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/24/2023

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: 254500184
• Device Lot Number: NW219016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 09/04/2023; 09/14/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 09/03/2023; 09/04/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown