MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRL SZ3 7MM; KNEE INSTRUMENT : TIBIAL TRIALS

Catalog Number	202411307
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument was bent and broken.
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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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).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.Was there a surgical delay because of this event? if yes, what is the duration of the delay? b.Were there any adverse consequence/s that affected the patient because of the reported event? c.What part of the instrument was broken? d.Did it break into two or more pieces? if no, please specify what is the alleged deficiency, is it dull, bent, cracked, stripped, scratched, worn, scratched, cross-threaded, or any device interaction issues? a) no.B) no.C) the end of the instrument.D) 2 pieces.The instrument was bent accidentally and broken.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that the instrument was bent accidentally and broken.They have another case.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the sigma hp uni tib trl sz3 7mm was found broken into two parts at one end.The broken fragment was returned for examination.No bending condition was observed, however, it can be attributed to being previously bent, and subsequently, the device was broken.Therefore, the reported condition can be confirmed.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces like usage of excessive force in a prying or removal motion while under load.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the sigma hp uni tib trl sz3 7mm 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: a manufacturing records evaluation (mre) was not performed as no valid lot number was provided for this device.

• Brand Name: SIGMA HP UNI TIB TRL SZ3 7MM
• Common Device Name: KNEE INSTRUMENT : TIBIAL 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18475285
• Report Number: 1818910-2024-00636
• Device Sequence Number: 6895560
• Product Code: HWT
• UDI-Device Identifier: 10603295082774
• UDI-Public: 10603295082774
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/09/2024

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: 202411307
• Device Lot Number: BF1009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 01/09/2024; 02/01/2024; 02/15/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 01/11/2024; 02/02/2024; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2009
• 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 Age: 58 YR
• Patient Sex: Male