MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN; SCREW, FIXATION, BONE

Catalog Number	04.211.016TS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Skin Inflammation/ Irritation (4545)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study no: no information provided.Date of event: 3 dec 2025 date of implant: (b)(6) 2025 device location: left.¿ postoperative adverse event: "pain/discomfort/prominence" ¿ is the ae related to the implantation or explantation of the hook plate? "possible" ¿ is the ae related to the investigational device (va clavicle plate/va clavicle hook plate)? " possible" ¿ is the ae related to the condition under investigation? ¿possible¿ ¿ dps implant was used.Device related: possible procedure related: possible device location: left.Treatment: implant removal, the event resulted in a medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.Depuy synthes products used: catalog number: 04.112.814s lot number: no information provided component type: plate description: 2.7mm ti va lcp hook plate long/ 15mm/ left/ sterile.Catalog number: 04.211.014ts lot number: no information available component type: screw description: va lockscr ã¸2.7 he 2.4 self-tap l14 tan.Catalog number: 04.211.014ts lot number: no information available component type: screw description: va lockscr ã¸2.7 he 2.4 self-tap l14 tan.Catalog number: 04.211.014ts lot number: no information available component type: screw description: va lockscr ã¸2.7 he 2.4 self-tap l14 tan.Catalog number: 04.211.014ts lot number: no information available component type: screw description: va lockscr ã¸2.7 he 2.4 self-tap l14 tan.Catalog number: 04.211.014ts lot number: no information available component type: screw description: va lockscr ã¸2.7 he 2.4 self-tap l14 tan.Catalog number: 04.211.014ts lot number: no information available component type: screw description: va lockscr ã¸2.7 he 2.4 self-tap l14 tan.Catalog number: 402.876ts lot number: no information provided component type: screw description: cortscr ã¸2.7 self-tap l16 tan.Catalog number: 04.211.016ts lot number: no information provided component type: screw description: va lockscr ã¸2.7 he 2.4 self-tap l16 tan.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
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.H11 additional narrative: added: d10, h6 health effect impact code.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24388614
• Report Number: 8030965-2026-01661
• Device Sequence Number: 10258215
• Product Code: HWC
• UDI-Device Identifier: 10886982119001
• UDI-Public: (01)10886982119001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.211.016TS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VA-LCP CLAVIC HOOK PL 2.7 LONG 9 LE SST.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 88 KG