MAUDE Adverse Event Report: SYNTHES GMBH AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.019.008
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on july 25, 2024, the multiloc system was used for the first time.The distal locking did not work properly because the drill did not hit the hole through the aiming arm.This caused the drill to become blunt.First it was thought that the drill was bent, but on august 5, 2024 a new nail was used to check all guiding holes of the aiming arm in a 'dry' state.It was noticed that the more proximal distal guiding hole must have a defect, as the protection- and drill-sleeve did not sit perfectly tight as in all the other holes.Therefore the drill was not guided completely smooth in the drill sleeve and hit the nail.This report involves one (1) aiming arm/lat/f/multiloc proximal humeral nail.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10 therapy date: july 25, 2024.E3: reporter is a j&j employee.H3, h6: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that aim arm/lat/f/multiloc proximal hum nl (03.019.008) had no evidence of device assemble or disassemble issue.The provided evidence was not sufficient to confirm the reported event.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the aim arm/lat/f/multiloc proximal hum nl would not contribute to the complained device issue.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.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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report corrected data: d4 primary udi number updated h6 health effect - impact code & clinical code updated device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, 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.H11 additional narrative: h3, h6: product investigation: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found nothing indicative of device nonconformance.The mating devices were not returned.However, a functional test was performed with 11.83, 11.96, 13.83- and 12.96-mm pin gages.The pin gages were placed through the holes in the aiming arm marked with red and blue.The device passes the test.The overall complaint was not confirmed as the observed condition of the aim-arm lat f/multiloc phn would not have contributed to the complained device issue.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 reported complaint condition.As part of j&j medtech orthopaedics 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 history review (dhr): part# 03.019.008.Lot # 3772727.Manufacturing site: werk hägendorf.Supplier ; na.Release to warehouse date: 03 may 2011.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified 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
Additional information was received stating that the event occurred during intra op.The operation could be performed satisfactorily.The surgeons were forced to dispense with one of the distal locks as the screw could not be placed due to the 'distorted' insertion handle.There is no allegation against the humerous nail or the drill bit.
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.H11 additional narrative: h3, h6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that aim arm/lat/f/multiloc proximal hum nl (03.019.008) had no evidence of device assemble or disassemble issue.The provided evidence was not sufficient to confirm the reported event.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the aim arm/lat/f/multiloc proximal hum nl would not contribute to the complained device issue.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.Device history review (dhr): part# 03.019.008.Lot # 3772727.Manufacturing site: werk hägendorf.Supplier ; na.Release to warehouse date: 03 may 2011.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF; im bifang 6; hägendorf CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19980923
• Report Number: 8030965-2024-09916
• Device Sequence Number: 18177936
• Product Code: HSB
• UDI-Device Identifier: 07611819425583
• UDI-Public: (01)07611819425583(11)110503(10)3772727
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103002
• 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

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: 03.019.008
• Device Lot Number: 3772727
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 08/15/2024; 09/30/2024; 10/22/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/05/2024; 10/01/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2011
• 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 - DRILL BITS: TRAUMA.; UNK - GUIDES/SLEEVES/AIMING: SLEEVE.; UNK - NAILS.
• Patient Sex: Unknown