MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM VAL T-PLATE 3 HOLES HD-7 HOLES SHAFT; PLATE, FIXATION, BONE

Catalog Number 02.130.252

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

Patient Problems Muscular Rigidity (1968); Loss of Range of Motion (2032)

Event Type  Injury  

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: d2: additional procode: hwc.D6: date of implantation is an unknown date between 2008 and 2023.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a synthes employee.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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

Hand plates in collaboration with depuy synthes, together with cleveland clinic foundation (ccf) database designers, program managers, research assistants, and biostatisticians, has developed a report that summarizes safety and effectiveness data on 67 patients who underwent hand surgery at ccf between 2008 and 2023 utilizing depuy synthes (dps) hand plates.Implants involved were lcp compact hand plates or va locking hand system.3 patients were noted to have more than one plate implanted.Dps screws were involved.Patient #19 42-year-old male was implanted with a va locking hand plates (02.130.252) with 6 screws.One additional adjunctive fixation biomaterials was used for comminution / bone loss post op complication was reported for persistent right small finger metacarpophalangeal joint posttraumatic stiffness, limited rom.The complication is noted to be related to the procedure or implants.There is no device failure noted.Treatment: removal of right fifth metacarpal plates and screws and extensor tenolysis, and dorsal metacarpophalangeal joint capsulotomy.This report is for a 1.5mm val t-plate 3 holes hd-7 holes shaft.This is report 1 of 7 for (b)(4).

• Brand Name: 1.5MM VAL T-PLATE 3 HOLES HD-7 HOLES SHAFT
• 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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19101087
• MDR Text Key: 340107113
• Report Number: 8030965-2024-05061
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982044792
• UDI-Public: (01)10886982044792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.130.252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• 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 - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male