MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP DIS FEM RESECT GUIDE; RESECTION BLOCKS/DEVICES

Catalog Number	950501235
Medical Device Problem Codes	Device-Device Incompatibility (2919); Mechanical Jam (2983); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
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 the instrument would not turn and the connector would not engage.It was unknown whether there was any surgical delay.
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.
Event or Problem Description
Additional information was received: a.Was there any patient harm/consequence related to the event? no b.Was there any surgical delay related to the event? no.
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 would not turn and the connector would not engage.It was unknown whether there was any surgical delay.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed that the sigma hp dis fem resect guide found corrosion around the laser engraving, marking it difficult to read.Since the coupling device was not returned, the condition of unable to assemble cannot be confirmed.However, a dimensional inspection was performed and met specifications.Where corrosion/oxidation is identified around the laser marks of the device, alongside damage consistent with normal wear, this suggests that the passive layer of the metal has been worn down from repeated use (due to normal use damage) allowing for the metallic surface underneath to become susceptible to corrosion/oxidation.Therefore, the potential cause of the observed corrosion/oxidation is consistent with the device reaching the end of its useful life.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A functional evaluation was performed where the guide dial rotate in both directions.Therefore, it was unable to replicate the jammed condition.The overall complaint was confirmed as the observed condition of the sigma hp dis fem resect guide would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to end of life 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.Dimensional inspection: drawing: dwg-114100 rev b.Feature: coupling inner diameter.Specification: 10.0512 +/- 0.0061 mm.Measured dimension: 10.05 mm.Device used: mitutoyo digimatic caliper (b)(6) id# (b)(4).Feature: coupling inner diameter.Specification: 10.0512 +/- 0.0061 mm.Measured dimension: 10.05 mm.Device used: gage pins (18¿ w x 12¿ h x 12¿ d) zz plus 0.21-13.99 mm id# (b)(4).Device history lot: a date code was provided, which indicates that the device was manufactured on (mfg date 3/15/2009).A manufacturing records evaluation (mre) was not performed since a valid finished good lot number was not provided for this device.

• Brand Name: SIGMA HP DIS FEM RESECT GUIDE
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 19589440
• Report Number: 1818910-2024-13628
• Device Sequence Number: 3506128
• Product Code: HWT
• UDI-Device Identifier: 10603295225409
• UDI-Public: (01)10603295225409(10)A0309
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/21/2024

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: 950501235
• Device Lot Number: A0309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 06/27/2024; 07/10/2024; 07/22/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 06/28/2024; 07/15/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2009
• 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 Sex: Male