MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT F/LATERAL CORTEX OPENING F/QUI

Catalog Number	03.037.021
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
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.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 on (b)(6) 2024, the patient underwent orif surgery via tfna for femoral intertrochanteric fracture on femur with the products in question.After the surgery, the surgeon informed the defect.In the surgery, when drilling the outer cortex before blade insertion, there was a sensation of interference with the nail, but drilled a little harder with several reverse rotations.The drill tip passed through the nail and proceeded to insert the blade, but only halfway through due to interference with the nail.Once the nail was removed and checked, the nail was found to have been scraped.The shaved nail was not used, a different size nail (125° 9mm extra short) was used, and the blade was inserted in a near freehand manner without sleeves of any kind.After that, the set screw was tightened without any problem, and a 130° aiming arm was used for the distal lateral stop.There were no problems with fixation.The surgery was completed successfully with 30 minutes surgical delay.No further information is available.
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 h3, h6: the device was 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.
Event or Problem Description
Additional information received states that there are no pieces in the patient.The surgeon confirmed by x-ray.
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: added: b5 corrected: g1 h3, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the drill bit f/lateral cortex opening f/qui was stripped from the cutter blades.Also signs of use were observed at the tip of the device.This condition is normal for this kind of reusable devices.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces a dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was unable to be performed due to the complete tfn-advanced proximal femoral nailing system devices were not returned.The overall complaint was confirmed as the observed condition of the drill bit f/lateral cortex opening f/qui 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.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 lot part:03.037.021 lot: f-18157 manufacturing site: werk selzach supplier: (b)(4) release to warehouse date:18 sep 2015 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: DRILL BIT F/LATERAL CORTEX OPENING F/QUI
• Common Device Name: DRILL BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20914649
• Report Number: 8030965-2024-14928
• Device Sequence Number: 8599728
• Product Code: HTW
• UDI-Device Identifier: 07611819642478
• UDI-Public: (01)07611819642478(10)F-18157
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/12/2024

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: 03.037.021
• Device Lot Number: F-18157
• 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: 11/28/2024
• Supplement Date Received by Manufacturer: 12/30/2024; 01/17/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/07/2025; 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown