MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM LCP(TM) T-PLATE 2 HOLES HEAD/7 HOLES SHAFT; PLATE, FIXATION, BONE

Catalog Number	249.670
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.H10 additional narrative: b3: event occurred on an unknown date in 2024.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial 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 or Problem Description
It was reported that on an unknown date in 2024 during a polytrauma case, a tfna was performed and the wire missed the nail.The nail was explanted and then discarded.A larger size of nail was used and the nail technique was successful.During a calcaneus fracture, a mod mini plate was used and the screw did not lock it.The screw was also inserted and the measurement of the screw was very long, and the screwdriver stripped the screw, the surgeon powered it in and stripped the screw head because it did not stop.The procedure was completed successfully with no surgical delay.There was no adverse patient impact no further information is available.This report is for a 2.4mm lcp(tm) t-plate 2 holes head/7 holes shaft.This is report 2 of 3 for (b)(4).

• Brand Name: 2.4MM LCP(TM) T-PLATE 2 HOLES HEAD/7 HOLES SHAFT
• Common Device Name: 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: 18622450
• Report Number: 8030965-2024-01560
• Device Sequence Number: 2466369
• Product Code: HRS
• UDI-Device Identifier: 10886982171207
• UDI-Public: (01)10886982171207
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 249.670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2024
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12/130 DEG TI CANN TFNA 460/RIGHT-SILE; DIRECT MEASURING DEVICE FOR 300MM WIRE; T30 CANN SD SCRWDRVR SFT SELF-RETAIN/LG; UNK - SCREWS: LOCKING
• Patient Sex: Unknown