MAUDE Adverse Event Report: SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.057S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
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 10mm/130 deg ti cann tfna 360mm/left ¿ sterile.This is report 1 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.H10 additional narrative: e3: initial reporter is a synthes employee.Manufacturing location: monument.Manufacturing date: 27-jun-2022.Expiration date: 30-sep-2032.Part number: 04.037.057s, 10mm/130 deg ti cann tfna 360mm/left ¿ sterile.Lot number: 2680p17 (sterile).Lot quantity: 12.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive.Lot number: 2557p37.Lot quantity: 400.Production order traveler met all inspection acceptance criteria.Inspection sheet.Ns673827 rev a met all inspection acceptance criteria.Part number: 04.037.942.2, lock prong 130 degree, tfna static locking prong.Lot number: 2582p48.Lot quantity: 218.Part number: 21127, timoagri16.00.Lot number: 919p725.Lot quantity: 1923 lbs.Inspection instruction met all inspection acceptance criteria.Certificate of test supplied by perryman company dated 29-jun-2022 was reviewed and determined to be conforming.Lot summary report dated 15-aug-2022 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.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 the 10/130 deg ti cann tfna 360/left - sile [04.037.057s/2680p17] was broken across the spiral blade insertion hole, both fragments were returned for evaluation.The edges of the fracture section do not indicate any signs of material issue, only smoothed out areas, most likely due to constant friction between the pieces before removal process.While no root cause can be established with the available information, factors such as the age of the patient, underlying disease, bone density, or a possible early weight-bearing, could have led to failure of the implant.A dimensional inspection for the10/130 deg ti cann tfna 360/left - sile [04.037.057s/2680p17] was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the t10/130 deg ti cann tfna 360/left - sile [04.037.057s/2680p17] 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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 10/130 deg ti cann tfna 360/left ¿ sile had broken at the mating point with the helical blade.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: 10MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 17914754
• Report Number: 8030965-2023-12859
• Device Sequence Number: 15327771
• Product Code: HSB
• UDI-Device Identifier: 10886982096135
• UDI-Public: (01)10886982096135
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• 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

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: 04.037.057S
• Device Lot Number: 2680P17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• 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: LOCKING SCREW FOR IM NAIL 5/ 34/ XL25; TFNA FENESTRATED HELICAL BLADE 90MM
• Patient Age: 58 YR
• Patient Sex: Female