MAUDE Adverse Event Report: SYNTHES GMBH 1.3MM TI LCKNG T-PLATE 3H HEAD/5H SHAFT-STERILE; PLATE, FIXATION, BONE

Model Number	04.130.152S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
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.Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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 or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent orif surgery for a finger fracture.The surgeon made the cut of the head part of the plate based on the understanding that a plate should be cut at the cut-line on the cutt-pliers, but the plate part in the long axis direction of the cutt-pliers was also cut.Therefore, the surgeon gave up using the plate and used another plate (y-type plate) for procedure.To cut the head part of the y-type plate, the surgeon used a hospital owned pin cutter.The surgery was completed successfully with no surgical delay.This report is for a 1.3mm ti lckng t-plate 3h head/5h shaft-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 1.3MM TI LCKNG T-PLATE 3H HEAD/5H SHAFT-STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO; via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15148615
• Report Number: 8030965-2022-05496
• Device Sequence Number: 20270712
• Product Code: HRS
• UDI-Device Identifier: 10886982112545
• UDI-Public: (01)10886982112545
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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 Model Number: 04.130.152S
• Device Catalogue Number: 04.130.152S
• Device Lot Number: 483P183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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: CUTT-PLIERS IN-LINE F/LOCK PL 1.3+VA LOC
• Patient Sex: Unknown