MAUDE Adverse Event Report: SYNTHES GMBH LOCKING SCREW FOR IM NAIL Ø 5MM/ 34MM/ XL25; SCREW, FIXATION, BONE

Catalog Number	04.045.034
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2023
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.H10 additional narrative: d2: additional procodes: hsb, jds.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes employee.The device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that the locking screw for im nail 5/ 34/ xl25 appear to be broken from the tip.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for locking screw for im nail 5/ 34/ xl25.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.
Event or Problem Description
It was reported that on (b)(6) 2023, the patient had a broken implant failure.A non-union occurred after 8 months with tfna.The nail was reported to have broken at the juncture of the helical blade.The revision procedure was completed successfully.No further information is available to report.This report is for a locking screw for im nail ø 5mm/ 34mm/ xl25.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: part 04.045.034s-us, lot 1863p15: manufacturing site: jabil grenchen.The product was released on: september 19, 2022.Expiry date: august 31, 2032.A manufacturing record evaluation was performed for the finished device and no nonconformances / manufacturing irregularities were identified during the manufacturing process.H6: a product investigation was completed: visual analysis of the returned sample revealed that had broken from the tip.The broken fragment was not returned for evaluation.The reported allegation can be confirmed.A dimensional inspection for the device was unable to be performed due to post manufacturing damage.The drawings reflecting the current and manufactured revisions were reviewed.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition would 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 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-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: LOCKING SCREW FOR IM NAIL Ø 5MM/ 34MM/ XL25
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17914766
• Report Number: 8030965-2023-12860
• Device Sequence Number: 20707280
• Product Code: HWC
• UDI-Device Identifier: 10886982292742
• UDI-Public: (01)10886982292742
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 04.045.034
• Device Lot Number: 1863P15
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10/130 DEG TI CANN TFNA 360/LEFT - SILE.; TFNA FENESTRATED HELICAL BLADE 90MM.
• Patient Age: 58 YR
• Patient Sex: Female