MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM VA PPFX GT HOOK PLATE SMALL; PLATE, FIXATION, BONE

Catalog Number	02.221.080
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).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.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that this complaint is from a data use agreement (dua).The preliminary data report was from the (b)(6), which includes information collected from (b)(6) hospital and (b)(6), as part of an on-going data use agreement.Attached is the interim version of the data collection template (dct), which includes safety-related information for the va-lcp ppfx system.A total of 13 complications have been reported across 10 patients.Seven of these led to revision or reoperation surgeries, with two cases considered device related¿specifically due to adverse tissue reaction and trochanteric bursitis.The remaining revisions were associated with pain, infection, nonunion, sepsis, and hardware prominence.Other reported complications include post-operative and intra-operative fractures, superficial infection, and one death due to natural causes.Subject number (b)(4), 69-year-old female.Patient experienced osteomyelitis requiring the removal of a loose plate and irrigation and debridement.Date of original surgery was on (b)(6) 2023.Implant(s) involved: 02.221.080 (1).Unknown cable (1), 3.5mm locking screw (1).
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: 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: 3.5MM VA PPFX GT HOOK PLATE SMALL
• Common Device Name: PLATE, 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: 23527749
• Report Number: 8030965-2025-11270
• Device Sequence Number: 9065697
• Product Code: HRS
• UDI-Device Identifier: 10886982275684
• UDI-Public: (01)10886982275684
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K210205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.221.080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White