MAUDE Adverse Event Report: SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 170MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.112S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
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.Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter occupation: initial reporter is a synthes 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 japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent the osteosynthesis with the tfna for the incomplete fracture of the trochanteric femur.Insertion of the nail and the blade was performed smoothly, and the locking mechanism was locked easily.After insertion of the locking screw, the end cap could not be inserted into proper position.The locking mechanism was unlocked with the screwdriver and tightening of locking mechanism was repeated.Then, the surgeon tried to insert the end cap; however, it could not be inserted.Therefore, all the implants were removed, and the surgeon checked the locking mechanism.When the surgeon tried to tighten the locking mechanism, it was hard.It required more force than usual to tighten the locking mechanism.The nail was changed to a different size.The surgery was completed successfully with 20 minutes delay.No further information is available.This report is for a 11mm/125 deg ti cann tfna 170mm ¿ 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.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.
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.H10 additional narrative: h3, h4, h6: 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 tfna fem nail ø11 125° l170 timo15 had the inner threads that mate with the lock prong assembly stripped; the prong of the lock prong assembly had friction marks on its outside distal end; and the lock star drive had screwdriver markings on its surface.A dimensional inspection was performed for the tfna fem nail ø11 125° l170 timo15 and met specifications.A functional test with a stardrive screwdriver was performed to assemble the lock prong assembly into the nail and there was no problem, although, there was a some resistance due to the stripped threads of the nail.The complaint condition was 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 tfna fem nail ø11 125° l170 timo15 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 history lot : manufacturing location: monument.Manufacturing date: 29-apr-2022.Expiration date: 01-apr-2032.Part number: 04.037.112s, 11mm/125 deg ti cann tfna 170mm- sterile.Lot number: 795p758 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual, sterility, 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: component parts were not reviewed as the reported complaint condition of ¿the end cap could not be inserted into proper position¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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: 11MM/125 DEG TI CANN TFNA 170MM - 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: 16362116
• Report Number: 8030965-2023-01712
• Device Sequence Number: 6757354
• Product Code: HSB
• UDI-Device Identifier: 10886982096302
• UDI-Public: (01)10886982096302
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131548
• 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 Model Number: 04.037.112S
• Device Catalogue Number: 04.037.112S
• Device Lot Number: 795P758
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 02/18/2023; 04/13/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/09/2023; 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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: UNK - END CAPS
• Patient Sex: Unknown