MAUDE Adverse Event Report: SYNTHES GMBH FLEX ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.612.010
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
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.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.
Event or Problem Description
Device report from synthes reports an event in canada as follows: it was reported that on (b)(6) 2023, the surgeon was tightening the flex arm to the insight tube, and found that the flex arm was no longer tightening.The flex arm was broken and needs to be replaced.The surgeon used the other flex arm from the set and completed the case.There was no delay or patient consequence.This report involves one flex arm.This is report 1 of 1 for (b)(4).
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.H3, h4, h6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photographs were reviewed, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs provided are not representative of the reported complaint condition.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 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.Physical investigation: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there were no damage or defects with the flex arm, only minor wear was observed on the surface of the device, which did not cause any functional issues.A dimensional inspection for the flex arm was not performed as it is not applicable to the complaint condition.A functional test was performed to device and the tensioning knob was able to be tightened to create sufficient rigidity of the flex arm.The band clamp knob was able to tighten completely.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the flex arm would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): part # 03.612.010 synthes lot # h499981 supplier lot # h499981 release to warehouse date: 28 june 2018 supplier: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: FLEX ARM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18266828
• Report Number: 8030965-2023-15347
• Device Sequence Number: 7891206
• Product Code: LXH
• UDI-Device Identifier: 10705034714486
• UDI-Public: (01)10705034714486
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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

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: 03.612.010
• Device Lot Number: H499981
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2018
• 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