MAUDE Adverse Event Report: SYNTHES GMBH AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.010.227
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in switzerland as follows: it was reported that during a surgery on (b)(6) 2023, the aiming instruments to lock an adolescent lateral entry femoral nail (alfn) nail proximally were damaged since the surgeon was not able to target the nail hole(s) correctly.The aiming arm was probably bent.The whole set was in a bad shape and dirty when it was in the operating room.Although all the instruments were processed before getting into the operating room, the instruments were still dirty.When the surgeon pressed through a cannulated instrument of this set, some human material (carrot of blood and/or tissues) got out.The patient had to stay longer in the operating room.The customer ordered a new set from another hospital to complete the surgery.This report is for one (1) aiming arm for adolescent lateral entry femoral nail-ex.This is report 1 of 1 for complaint (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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.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.
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.No device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The investigation could not draw any conclusions about the current reported event without the device to examine.Based on the inability to determine a root cause, a need for corrective action is not indicated.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary 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.
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.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
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
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: h3, h6: part#03.010.227.Lot # 3059117.Manufacturing site: (b)(4).Release to warehouse date: 20 feb 2009.Supplier: n/a.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot 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 analysis of the returned sample revealed that there was no damage or defects with the aim-arm f/expert alfn, hence the deformed condition cannot be confirmed.The device does not present any traces of foreign matter/human material, as reported in the event description.A dimensional inspection for the aim-arm f/expert alfn was not performed as it is not applicable to the complaint condition.A complete interactional test was unable to be performed as only the aiming arm and insertion handle, however, these two devices were assembled together, there were no signs of misalignment or malfunctioning that could contribute to the reported event.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 aim-arm f/expert alfn was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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 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: AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16438531
• Report Number: 8030965-2023-02324
• Device Sequence Number: 14234478
• Product Code: FZX
• UDI-Device Identifier: 07611819967526
• UDI-Public: (01)07611819967526
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,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: 03.010.227
• Device Lot Number: 3059117
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/08/2023; 05/02/2023; 06/01/2023; 06/15/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/24/2023; 05/04/2023; 06/16/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2009
• 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: CONNECSCR CANN F/EXPERT TN+FN F/03.010.0.; DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/.; INSERT-HANDLE F/EXPERT ALFN.; INSERT-HANDLE F/EXPERT ALFN.
• Patient Sex: Unknown