MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.019.024
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # :(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
It was reported that screw threads of extraction screw for multiloc humeral nail system were damaged.There was no change in technique, no patient consequence and no surgical delay.
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.H11 additional narrative: added: d9 the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Additionally, a visual inspection of the returned photo was performed.Visual inspection of the returned device found that the extractscr f/multiloc hum nail syst was stripped from the threaded tip at the distal end.There is no indication that a design or manufacturing issue has caused the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended force.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the extractscr f/multiloc hum nail syst would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure, and it has been determined that no corrective and/or preventative action is proposed.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: 03.019.024.Lot no: l830406.Release to warehouse date: 25 sep 2018.Manufacturing site: werk hagendorf.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: EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 20913733
• Report Number: 8030965-2024-14903
• Device Sequence Number: 15410103
• Product Code: HSB
• UDI-Device Identifier: 07611819427242
• UDI-Public: (01)07611819427242(10)L830406
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120807
• 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

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: 03.019.024
• Device Lot Number: L830406
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 01/07/2025; 01/24/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/08/2025; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2018
• 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
• Patient Sex: Unknown