MAUDE Adverse Event Report: SYNTHES GMBH TFNA END CAP EXTENS. 0 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.000S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent an open reduction internal fixation (orif) surgery for trochanteric fracture of femur.During surgery, the surgeon could not insert the end cap in question to a tfna nail.The surgeon tried to adduct the end cap, make the locking mechanism descend, but the surgeon could not insert the end cap.The surgeon gave up using the end cap and finished the procedure without inserting the end cap.Surgical delay of 30 minutes was noted.After surgery, the sales rep examined if the end cap could be inserted to a sample implant.The end cap could not even be inserted to the sample implant.The threads on the end cap don¿t seem to be equal intervals, and it seems deformed.Concomitant device reported: unk - nails: tfna (part# unknown; lot# unknown; quantity: unknown).Unk insertion instrument: trauma (part# unknown; lot# unknown; quantity: unknown).This is report 1 of 1 for (b)(4).This report is for an end cap.
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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
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: part #: 04.038.000s.Lot #: 727p383.Manufacturing site: jabil bettlach.Release to warehouse date: 11 april 2022.Expiry date: 01 march 2032.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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 end cap extens.0 tan was stripped from the threaded section.Assembling issues are most likely due to this condition.A dimensional inspection for the tfna end cap extens.0 tan was unable to be performed due to post manufacturing damage.A functional test was unable to be performed since the mating device was not returned.The complaint condition was not 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 end cap extens.0 tan 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 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: TFNA END CAP EXTENS. 0 TAN
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15087772
• Report Number: 8030965-2022-05110
• Device Sequence Number: 14696091
• Product Code: HSB
• UDI-Device Identifier: 10886982098344
• UDI-Public: (01)10886982098344
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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 Model Number: 04.038.000S
• Device Catalogue Number: 04.038.000S
• Device Lot Number: 727P383
• 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: 06/23/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2022
• 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 - NAILS: TFNA.; UNK INSERTION INSTRUMENT: TRAUMA.
• Patient Sex: Unknown