MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE SHIM SZ7 8MM; TIBIAL INSERT TRIALS

Catalog Number	254500673
Medical Device Problem Codes	Break (1069); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the attune shim from bph consignment set was damaged.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - according to the information received, "damaged attune shim from bph consignment set".The product was not returned to depuy synthes, however photos were provided for review.See attachment ¿(b)(4) image¿.The photo investigation revealed that bottom edge of the (b)(4), attune shim sz7 8mm is chipped off.This type of damage is consistent with other tools and hard edges coming in contact with the device and usage of excessive force in a prying motion while trialing.Properly handling and attention to the approved use of the device diminishes the risk of failure.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the (b)(4), attune shim sz7 8mm would contribute to the complained device issue.Based on the investigation findings, potential cause can be traced to unintended user 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 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 device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : received an email from qld warehouse stating they received a damaged attune shim from bph consignment set.I was not aware of this damaged item but was asked to log the broken instrument.The item is in possession of the qld warehouse.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the attune shim sz7 8mm was chipped off at the bottom edge.However signs of scratches were not observed.This type of damage is consistent with the device being in contact with other tools like: forceps, tweezers or other tools with and edge.Properly handling and attention to the approved use of the device diminishes the risk of failure.The overall complaint was confirmed as the observed condition of the (b)(4), attune shim sz7 8mm would contribute to the complained device issue.Based on the investigation findings, potential cause can be traced to unintended user 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 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.
Event or Problem Description
Additional information from the loan kit team: the shim has a gouge out of the plastic.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "damaged attune shim from bph consignment set." the product was not returned to depuy synthes, however photos were provided for review.See attachment ¿ (b)(4) image¿.The photo investigation revealed that bottom edge of the 254500673, attune shim sz7 8mm is chipped off.However, it is not possible to confirm the scratched condition of the device.This type of damage is consistent with other tools and hard edges coming in contact with the device and usage of excessive force in a prying motion while trialing.Properly handling and attention to the approved use of the device diminishes the risk of failure.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 254500673, attune shim sz7 8mm would contribute to the complained device issue.Based on the investigation findings, potential cause can be traced to unintended user 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 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 SHIM SZ7 8MM
• Common Device Name: TIBIAL INSERT TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18076185
• Report Number: 1818910-2023-22644
• Device Sequence Number: 7692840
• Product Code: HWT
• UDI-Device Identifier: 10603295133551
• UDI-Public: 10603295133551
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 11/06/2023

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: 254500673
• Device Lot Number: MVMBTH270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 11/07/2023; 11/17/2023; 12/26/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/08/2023; 11/27/2023; 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2014
• 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