MAUDE Adverse Event Report: SYNTHES GMBH INSERT-HANDLE F/EXPERT TN+FN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.010.045
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure on (b)(6) 2022, the surgeon had an antegrade rafn fully inserted into the femur.He began to rotate the nail with the insertion handle.An audible pop was heard and it was evident that something was amiss when the proximal targeted interlocks missed through the aiming arm.Upon completion of the procedure, it was noticed that the tooth that connects the nail to the insertion handle had broken off, making the insertion handle rotate freely around the nail.The tooth remained in the proximal portion of the nail.The patient had a left femoral shaft fracture.There was a surgical delay of 8 minutes.Perfect circles were completed proximally, and the surgery was completed successfully.The fragments were retained in the patient.There was no clinical outcome experienced by the patient.No other medical intervention was necessary.This report involves one standard insertion handle.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 device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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
The pin in the driving cap came out and the spring mechanism fell apart.
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.Part: 03.010.045, lot: 1620767, manufacturing site: hägendorf, release to warehouse date: 19.Jan.2007.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Note: device history record review was acquired from product investigation (b)(4), as both impacted products share the same lot number.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 the extrusion at the end of insert-handle f/expert tn+fn, p/n: broke off.The broken fragment was not returned for evaluation.The embedded device allegation can not be confirmed since no evidence to assess the condition was provided.A dimensional inspection was unable to be performed due to post-manufacturing damage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the insert-handle f/expert tn+fn, p/n: would 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.Drawing/specifications reviewed: rev n current, l manufactured dimensional inspection: n/a.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: INSERT-HANDLE F/EXPERT TN+FN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF; im bifang 6; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15996964
• Report Number: 8030965-2022-11219
• Device Sequence Number: 17584369
• Product Code: LXH
• UDI-Device Identifier: 07611819760837
• UDI-Public: (01)07611819760837
• Combination Product (Y/N): N
• 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: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.010.045
• Device Catalogue Number: 03.010.045
• Device Lot Number: 1620767
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAILS: RAFN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown