MAUDE Adverse Event Report: SYNTHES GMBH INSERT-HANDLE F/MULTILOC HUM NAIL SYST; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.019.006
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is a j&j employee.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2022, that during an unknown procedure, it was observed that the insertion arc of the multiloc humeral nailing (mhn) system at the moment of inserting the nail, began to loosen and the surgeon needed to rearrange the nail.During the removal of the device to rearrange the nail, it was observed that the connection with the insertion arc was not gripping well, and the top of the nail raised a fragment.The surgeon fixed that part and introduced the nail again; however, it continued to fail and interfered with the proximal locking since it did not match.An option was given of changing the nail for another, but the surgeon preferred to continue.When performing the freehand distal locking, the surgeon requested a 2.5 drill bit with a smaller diameter and at the time of impacting, it bended, and the 3.2 drill bit was passed, which was the recommended one, and at the time of impacting it and after drilling it also it bended.There was a surgical delay to the procedure and the surgery was completed successfully.No fragments were generated.No further information is available.This report involves one (1) insert-handle f/multiloc hum nail syst.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9 h3, h6: part: 03.019.006.Lot: l366364.Manufacturing site: hagendorf.Supplier: n/a.Release to warehouse date: october 17, 2017.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 insert-handle f/multiloc hum nail syst was observed dented near from the pin and body device, the connection part with the nail was broken.The broken part was not received in the evidence provided.A dimensional inspection for the insert-handle f/multiloc hum nail syst was unable to be performed due to post manufacturing damage.A functional test was performed was unable to be performed due to mating device (nail) was not received.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 confirmed as the observed condition of the insert-handle f/multiloc hum nail syst 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.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/MULTILOC HUM NAIL SYST
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14120580
• Report Number: 8030965-2022-02476
• Device Sequence Number: 11369523
• Product Code: HSB
• UDI-Device Identifier: 07611819425569
• UDI-Public: (01)07611819425569
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 04/15/2022

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: 03.019.006
• Device Lot Number: L366364
• 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: 03/20/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2017
• 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: DRILL BIT Ø2.5 L110/85 2FLUTE F/QC.; DRILL BIT Ø3.2 CALIBR L145 3FLUTE.; INSERT-HANDLE F/ML HUM NAIL.; UNK - NAILS.
• Patient Sex: Unknown