MAUDE Adverse Event Report: SYNTHES GMBH AIM-ARM LAT F/MULTILOC PHN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.019.008
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent an orif with the mhn for proximal humerus fracture.After opening the package of the nail, the drill bit interfered with the nail outside the body during at the check.During surgery, the drill bit interfered with the nail again.The surgery was completed successfully without any surgical delay.The surgeon requested that the product be shipped after a thorough inspection for carbon wear.No further information is available.This report is for one (1) aiming arm/lat/f/multiloc proximal humeral nail this is report 1 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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: d4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D9: the product was returned to depuy synthes for evaluation.E3: reporter is a j&j sales representative.Investigation summary: visual inspection of the returned device found nothing indicative of a device nonconformance.The mating devices were not returned.However a functional test was preformed.The pin gage was place through the holes in the aiming arm and the pin gage passed without problems.The overall complaint was not confirmed as the observed condition of the aim-arm lat f/multiloc phn would have not 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 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.The subject device has been received.The drawings reflecting the current and manufactured revisions were reviewed: rev h current.Rev f manufactured dimensional inspection: n/a device used: vermont gage part# 102100200 device history lot part # 03.019.008 lot # 3l37164 manufacturing site: (b)(6) release to warehouse date: 08 may 2019 expiration date: n/a supplier: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: AIM-ARM LAT F/MULTILOC PHN
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAGENDORF; im bifang 6; hagendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20091939
• Report Number: 8030965-2024-10458
• Device Sequence Number: 12652741
• Product Code: HSB
• UDI-Device Identifier: 07611819425583
• UDI-Public: (01)07611819425583(11)190508(10)3L37164
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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

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: 3L37164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2019
• 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: HUMERAL; UNKNOWN DRILL BITS
• Patient Sex: Unknown