MAUDE Adverse Event Report: SYNTHES GMBH PROTECTION SLEEVE Ø14; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.033.007
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on november 4, 2024, during a training session, the item got blocked without having being used.There was no reason for it to block/get defective.There was no patient involvement.
Additional Manufacturer Narrative
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: the product was not returned to medtech orthopaedics, however photos were provided for review.H3, h6: the photo investigation did not reveal that protection sleeve ø14 (03.033.007) had any disassemble issue.The provided evidence was not sufficient to confirm the reported event.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the protection sleeve ø14 would not contribute to the complained device issue.Based on the investigation findings 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 medtech orthopaedics 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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.Added: b14 (to capture dhr).D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary: according to the information received, "during a training session, the item got blocked without having been used." device history review (dhr): part number: 03.033.007-15.Lot number: 6961p08.Manufacturing site: hägendorf.Release to warehouse date: 11-sep-2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.The capa jbl-nr-0023964 was opened to investigate citric passivation being used instead of nitric passivation.This ncis affecting passivation only and is not related to the complaints l, but to the usage of citric passivation being used instead of nitric passivation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.Added: d9.H3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the quick coupling component was broken from the weld, causing separation from the sleeve.The component remained attached the mating handle (product code: 03.010.500).A functional test was performed, dissembling attached components and failed.Breakage of the device was consistent with a component failure that was caused by exposure to unintended forces.However, a complete potential cause can not be determined for the inability to disengage both devices.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the protection sleeve ø14 would have contributed to the complained device issue.Based on the investigation findings, 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 j&j medtech orthopaedics 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 review part number: 03.033.007-15 lot number: 6961p08 manufacturing site: hägendorf release to warehouse date: 11-sep-2023 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.The capa jbl-nr-0023964 was opened to investigate citric passivation being used instead of nitric passivation.This ncis affecting passivation only and is not related to the complaints l, but to the usage of citric passivation being used instead of nitric passivation.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PROTECTION SLEEVE Ø14
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF; im bifang 6; hägendorf CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20696047
• Report Number: 8030965-2024-13993
• Device Sequence Number: 3850463
• Product Code: LXH
• UDI-Device Identifier: 07612334121837
• UDI-Public: (01)07612334121837(10)6961P08
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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

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: 03.033.007
• Device Lot Number: 6961P08
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 11/19/2024; 01/20/2025; 01/20/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 11/25/2024; 01/20/2025; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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