MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 10MM; SCREW, FIXATION, BONE

Model Number	04.211.010
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
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.Complainant part is not expected to be returned for manufacturer review/investigation.Part # 04.211.010ts.Lot # 8l82284.Manufacturing site: (b)(4).Release to warehouse date: 23 nov 2021.Expiration date: 01 nov 2026.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.211.010.Non-sterile lot # 465p774.Manufacturing site: (b)(4).Release to warehouse date: 28 oct 2021.Supplier: (b)(4).Product was not returned.Based on the information available, it has been determined that no corrective and 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 synthes reports an event in (b)(6) as follows: it was reported that the patient underwent an open reduction/internal fixation of the clavicle on (b)(6) 2022.While the surgeon was fixing the medial fragment with the cs1 plate, the surgeon drilled, measured, and manually inserted the appropriate locking screws with va sleeve.However, the screw had a piece of metal on it and was not torqued.Similarly, when the surgeon drilled, measured, and inserted the relevant product with a va sleeve into another hole, it was torqued and used without problems.The surgeon commented that it happened because the screw went in at a stronger oblique angle than the direction in which it was drilled.The surgeon confirmed by x-ray that there were no pieces left in the patient.There was no problem with bone fixation.There was no surgical delay in relation to this event.No further information is available.This report involves one 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 10mm.This is report 2 of 2 for (b)(4).

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 10MM
• 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 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15632010
• Report Number: 8030965-2022-08423
• Device Sequence Number: 20818582
• Product Code: HWC
• UDI-Device Identifier: 10886982118950
• UDI-Public: 10886982118950
• 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: Physician
• 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: 04.211.010
• Device Catalogue Number: 04.211.010TS
• Device Lot Number: 8L82284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• 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 - GUIDES/SLEEVES/AIMING: GUIDE; VA-LCP CLAVIC PL 2.7 SHAFT CS1 LE TAN
• Patient Sex: Unknown