MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 14MM; SCREW, FIXATION, BONE

Catalog Number	412.814S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that the patient underwent an open reduction/internal fixation surgery for a distal ulna fracture with the distal radius plate and locking screws on (b)(6) 2024.After the surgeon fixed the plate with three cortex screws, he inserted locking screws at the distal and proximal ends, but the locking screws penetrated the screw holes in the plate.The sales representative also confirmed that the locking screw penetrated through the screw hole without getting caught.The surgeon determined that fixation could not be achieved in this condition, so the distal radius plate was removed, and the wound was switched to a fixation with a k-wire and closed.The surgery was extended by 30 minutes due to the event, and the patient status/outcome was reported to be stable.This report involves one 2.4mm ti locking scr slf-tpng with stardrive recess 14mm.This is report 1 of 3 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.D2b: additional device product codes: hrs d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: 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.H3, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found the threads stripped, this issue can be related to the reported allegation of unable to assemble.It is important to mention that insertion of the screw through the plate should be performed according to established procedure, overtightening can lead to an incorrect interaction of the devices.Surgical technique se_839084 page 10 mentions for inserting locking screw: insert the locking screw manually with the self-retaining stardrive screwdriver.Carefully tighten the locking screw, as excessive force is not necessary to produce effective screw locking.A dimensional inspection for the device was unable to be performed due to post manufacturing damage.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 of the lockscr ã¸2.4 self-tap l14 tan would contribute to the complained device issue.Based on the investigation findings, and 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.
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.The video attached was reviewed, only one lockscr ã¸2.4 self-tap l14 tan is observed and lot number is not noticeable but two were documented, investigation analysis can only be performed for one device.Investigation revealed that locking screw can easily pass through some of the holes of the plate.It is not possible by evidence provided to assure if plate or screw are defective.However, it is important to mention that insertion of the screw through the plate should be performed according to established procedure, overtightening can lead to an incorrect interaction of the devices.Insert the locking screw manually with the self-retaining stardrive screwdriver.Carefully tighten the locking screw, as excessive force is not necessary to produce effective screw locking.The overall complaint was confirmed as the observed condition of the lockscr ã¸2.4 self-tap l14 tan 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 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 history part: 412.814s, lot no: 5l93024, release to warehouse date: 05 sep,2019, manufacturing site: werk selzach.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were 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.

• Brand Name: 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18608799
• Report Number: 8030965-2024-01627
• Device Sequence Number: 14164274
• Product Code: HWC
• UDI-Device Identifier: 10886982211613
• UDI-Public: (01)10886982211613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103243
• 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 Catalogue Number: 412.814S
• Device Lot Number: 5L93024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 02/27/2024; 04/12/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/15/2024; 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2019
• 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: LCP DORSAL DIST-RADIUS PL2.4 STRAIG 6HO; LOCKSCR ø2.4 SELF-TAP L14 TAN
• Patient Sex: Unknown