MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 22MM; SCREW, FIXATION, BONE

Model Number	212.107
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: devices were not explanted but a revision is expected.Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.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.Code not available is for injury/revision surgery needed.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 france as follows: it was reported on (b)(6) 2022 there was lack of locking of 2.7 mm locking screws in two (2) low compression plate (lcp) elbow plates with a dynamometric screwdriver intraoperatively.Several screws bent and there were two (2) edges on one side.The patient was immobilized for ten (10) days and x-rays were taken.A surgical revision is planned to remove everything but has not yet been completed.Implants are still currently implanted in the patient.This is report 7 of 12 for (b)(4).This report is for a locking screw.
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: b5: subsequent follow-up with the customer, additional information was received regarding the event.It was reported that there was unlocking of the screw relative to the plate and retraction of the screws.It was reported that the customer encountered an incident with the 2 lcp plates.It was reported that the implant had been in the patient for 10 days.It was reported that there was a cast immobilization investigation summary : 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 history review : product code:212.107ts.Lot number: 103p132.Manufacturing site: mezzovico.Release to warehouse date: 29 jun 2021.Expiration date: 01 may 2026.A manufacturing record evaluation was performed for the sterile lot number, and no non-conformances were identified.

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 22MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15073607
• Report Number: 8030965-2022-05019
• Device Sequence Number: 14796887
• Product Code: HWC
• UDI-Device Identifier: 10886982151810
• UDI-Public: (01)10886982151810
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: 212.107
• Device Catalogue Number: 212.107TS
• Device Lot Number: 103P132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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: LOCKSCR ø3.5 SELF-TAP L22 SST; LOCKSCR ø3.5 SELF-TAP L26 SST; VA LOCKING SCREW STARDRIVE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA LOCKING SCREW STARDRIVE® ÿ 2.7 MM (HE; VA-LCP DHP 2.7/3.5 LAT LE MED 2HO L82 SS; VA-LCP DHP 2.7/3.5 MED LE LONG 4HO L108
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown