MAUDE Adverse Event Report: SYNTHES GMBH INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.008.007
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.A photo-investigation was performed on the image located in pc attachment (b)(4).Upon investigating the image provided, the distal end of insert-handle f/expert han appears little deformed.Additionally, the lot number is blurry to verify based on the available image.The root cause of the deformed insert handle cannot be confirmed based on the available image.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot.Part # 03.008.007.Lot # 4l14679.Part/lot combination are unknown at synthes gmbh, no dhr review possible.Device history batch null.Device history review null.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 (b)(6) as follows: it was reported that on (b)(6) 2021, the t-chuck handle did not function properly anymore.The handpiece detached from the body of the instrument.The two connections of the aiming device are damaged.The notches of the nail did not fit into the two protrusions of the aiming device.No patient consequence or impact during the surgery.This is report 1 of 3 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.Photo investigation: the device was not returned.A photo-investigation was performed on the image provided.Upon investigating the image provided, the distal end of insert-handle f/expert han appears little deformed.Additionally, the lot number is blurry to verify based on the available image.The root cause of the deformed insert handle cannot be confirmed based on the available image.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Visual inspection: the insert-handle f/expert han (part #: 03.008.007, lot #: 4l14679) was received at us cq.Visual inspection of the complaint device showed surface scratches and nicks at the proximal end.No other issue was observed.Functional test: a functional assessment was not performed with the complaint device since the applicable mating component(s) were not returned.Can the complaint be replicated with the returned device? no.Dimensional inspection: no inspection was performed as there was no damage that warranted dimensional inspection.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as the unable to assemble condition reported was not able to be tested and confirmed; however surface scratches and nicks were observed.No root cause could definitively be determined for the reported complaint condition based on the available information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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 lot part # 03.008.007, lot # 4l14679.Part/lot combination are unknown at synthes gmbh, no dhr review possible.,part # 03.008.007, lot # 4l14679, release to warehouse date: 27 jun 2019 , manufacturer: hagendorf , no ncr's were generated during production.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: INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11893100
• Report Number: 8030965-2021-04333
• Device Sequence Number: 3710772
• Product Code: FZX
• UDI-Device Identifier: 07611819868540
• UDI-Public: (01)07611819868540
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: 03.008.007
• Device Lot Number: 4L14879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/28/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNIV-CHUCK W/T-HANDLE; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - NAILS; UNIV-CHUCK W/T-HANDLE; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - NAILS