MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE 0 DEG LEFT CUT BLOCK; RESECTION BLOCKS/DEVICES

Catalog Number	254400014
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that broken pin wouldn't free from cutting block.Check against other pins this revealed that none of the pins would fit correctly and likely the metal hole had perhaps warped out of shape and would not function correctly.The same pins were compared to the right cutting block on this tray and performed as intended.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: a.What was the exact allegation against the device? was it worn, cracked, broken into pieces, bent, stripped, cross threaded or any device interaction? the cutting block appeared worn and would no longer allow for the pin to pass through.B.Was there a surgical delay? if yes, what is the duration of the delay? minimal delay as the screw hole is for additional security of the block.C.Was there any adverse consequences that affected the patient because of the reported event? none.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - according to the information received, ¿upon inspection by the rep, he managed to free the broken pin and check the cutting block against other pins ¿ this revealed that none of the pins would fit correctly and likely the metal hole had perhaps warped out of shape and would not function correctly.¿the same pins were compared to the right cutting block on this tray and performed as intended.The product was not returned to depuy synthes; however, photos were provided for review.See attachment ((b)(4) attune 0 deg left cut block 254400014).On of the provided photos revealed that a pin has fractured and remains inside de attune 0 deg left cut block.Additionally, the device presents an overall worn condition consistent with normal and constrain usage for around 8 years.Nicks were also observed at the corner of the cutting slot, consistent with the cutting blade making contact with the outer edge of the cutting slot during bone preparation.However, no signs of deformation on the insertion hole were observed on the provided photos.The observed condition of the device may suggest difficulties during the assembling process, most likely due to an off axis insertion of the pin and an exposure to unintended forces, like usage of excessive force in a prying motion during the assembling process.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the attune 0 deg left cut block would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is proposed.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 manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE 0 DEG LEFT CUT BLOCK
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19664512
• Report Number: 1818910-2024-14573
• Device Sequence Number: 17779415
• Product Code: HTZ
• UDI-Device Identifier: 10603295421078
• UDI-Public: (01)10603295421078(10)PG286797
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 07/03/2024

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: 254400014
• Device Lot Number: PG286797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 07/04/2024; 09/20/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/08/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2016
• 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