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	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Device deemed reportable at conclusion of investigation on 04apr2023.Initial reporter is j&j company representative investigation summary the product was returned to depuy synthese for evaluation.The depuy synthese 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 slightly stripped from the proximal and distal ends of the external threads.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces while assembling the end cap into the nail.A dimensional inspection was performed for the tfna end cap extens.0 tan and met specifications.A functional test was unable to be performed as its mating device was not returned.However, interaction issues with the tfna nail are most likely due to the stripped condition of the end cap.The complaint condition was not able to be replicated.As part of depuy synthese 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.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.Drawing/specifications reviewed? yes, reviewed dimensional inspection: specified dimensions: major diameter of the external threads = m11x1 - 6g (10.794-10.974mm per ansi/asme b1.13m-1995) measured dimensions: major diameter of the external threads = 10.85 mm (conforming) device history part number: 04.038.000s lot number: 901p957.Manufacturing site: jabil bettlach.Release to warehouse date: 13/07/2022.Expiry date: 01/07/2032.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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 synthese reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent osteosynthesis for femoral intertrochanteric fracture with the end cap.A physician with over 100 cases of tfna experience was in the room as an assistant, and he took over for the primary surgeon, but could not get the end cap in.They checked axial projection but it was in, so the cause was unknown.The set screws are also checked by the nips of the screwdrivers to make sure they are down.Since the end cap was placed immediately after the device was removed, it is unlikely that a soft part intervened.The surgery was completed successfully within 30 minutes delay.Concomitant device: unknown nail, unknown part/lot.This is report 1 of 1 for (b)(4).This report is for tfna end cap extens.0 tan.

• 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): BETTLACH; muracherstrasse; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16682810
• Report Number: 8030965-2023-04174
• Device Sequence Number: 7293579
• 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: 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 Model Number: 04.038.000S
• Device Catalogue Number: 04.038.000S
• Device Lot Number: 901P957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown