MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM LCP DISTAL ULNA PLATE 7 HOLE-STERILE; PLATE, FIXATION, BONE

Catalog Number	242.531S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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 repornown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: specific lot number unknown.Without the lot number dhr cannot be performed.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
It was reported that this complaint is from a data use agreement (dua).The dua summarizes 7 patients that were implanted with depuy synthes (dps) lcp 2.0 distal ulna plate.Implantation was between 2008 and 2023 at cleveland clinic foundation (ccf).Patient number 5.Patient is a 68-year-old female who underwent distal ulna fracture fixation.Reason for implantation was sub capital fracture (extra-articular).Post op complication included ulnar plate failure - but maintained good position.Implant(s) involved: 242.531s.Combination screws x5 02.111.531.Combination screw x9.
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.H11 additional narrative: h3, h6: 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.

• Brand Name: 2.0MM LCP DISTAL ULNA PLATE 7 HOLE-STERILE
• 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: 22100623
• Report Number: 8030965-2025-05360
• Device Sequence Number: 8354151
• Product Code: HRS
• UDI-Device Identifier: 10886982168757
• UDI-Public: (01)10886982168757
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare 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: 242.531S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 06/10/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/12/2025; 06/12/2025
• 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
• Patient Age: 68 YR
• Patient Sex: Female