MAUDE Adverse Event Report: SYNTHES GMBH HOLDING+DISTRACTION INSTR F/ECD; MISC ORTHO SURGICAL INSTR

Catalog Number 397.127

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

Event Description

Device report from synthes reports an event in switzlerland as follows: it was reported that there were 2 issues while placing the ecd implant in-situ.The expansion mechanism almost immediately stopped working: the metal toothed wheel from the implant holder seemed not to hold and was thus sliding over the teeth of peek wheel from the implant (with a typical ¿click¿ feedback noise).The implant holder was properly mounted.The surgeon took away the implant from the anatomy and tried the extension mechanism freely, it worked.Then, the surgeon tried the expansion with the cage¿s endplates between it¿s fingers, thus applying a very little force on the endplates.Under this configuration, although the implant holder was perfectly positioned (orthogonal) regarding the implant, the metal wheel started sliding again over the peek toothed wheel of the implant (typical ¿click¿ feedback noise).It was also reported that it was impossible to release the implant once placed into the anatomy.The implant couldn¿t be released from the holding prongs.Since the holding prongs were successfully tested prior the surgery.The surgeon however managed to place the cage in situ without the dedicated implant holder, but with tweezers.The x-ray control confirmed that the position and the extension of the cage were correct.Surgery was delayed 10 minutes.Surgery was completed successfully.This report is for one (1) holding+distraction instr f/ecd.This is report 1 of 1 for complaint (b)(4).

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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.H3, h4, h6: part number: 397.127, lot number: 6789p16, manufacturing site: hägendorf, release to warehouse date: 13-july-2023.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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 one of the jaws is slightly bended to the inside.Furthermore the rotary knob handle of the device is loose; it easily rotates all the way and easily falls off.Even though a functional test cannot be completely performed without mating device, it is not unreasonable this condition can contribute with the reported issue.A dimensional inspection was unable to be performed due to post manufactured damage.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the holding+distraction instr f/ecd would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to a component failure, 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 was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HOLDING+DISTRACTION INSTR F/ECD
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18595530
• MDR Text Key: 334077614
• Report Number: 8030965-2024-01437
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819162617
• UDI-Public: (01)07611819162617
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397.127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1