MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7 VA-LCP 2-C DRP STD 6H HD/13H SHAFT/186MM/RT-STER; PLATE, FIXATION, BONE

Model Number 02.111.690S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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.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 Description

It was reported that on an unknown date, there was intra-articular fracture fixation for distal radius with extension to radial diaphysis.Postoperative complication was extensive bone loss from trauma required bone grafting at a later date.This report is for one (1) 2.4/2.7 va-lcp 2-c drp std 6h hd/13h shaft/186mm/rt-ster this is report 1 of 12 for complaint (b)(4).

• Brand Name: 2.4/2.7 VA-LCP 2-C DRP STD 6H HD/13H SHAFT/186MM/RT-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15642396
• MDR Text Key: 302160263
• Report Number: 8030965-2022-08575
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982032195
• UDI-Public: 10886982032195
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.111.690S
• Device Catalogue Number: 02.111.690S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: VA-LCP; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female