MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: PROXIMAL TIBIA PLATE; PLATE, FIXATION, BONE

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2024

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.H10 additional narrative: d1, d2, d3, d4, g5 ¿ 510k: this report is for an unk - plates: proximal tibia plate lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1:(b)(6) hospital (b)(6).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

Device report from synthese reports an event in japan as follows: it was reported that on (b)(6) 2024, the patient underwent an osteosynthesis for a fracture of the proximal end of the tibia.The ptp was placed on the lateral.1 cortex screw was inserted in the oval hole and 4 locking screws were inserted in the joint side.The surgeon then inserted a locking screw in the most distal hole and tried to manually attach a 2.8 mm threaded drill guide to the 2nd hole from the distal end but was unsuccessful.The surgeon then managed to attach the drill guide to the 2nd hole from the distal end and inserted the 38mm locking screw, but torque could not be applied.The surgeon exchanged the 38mm locking screw with the cortex screw and inserted it, but torque could not be applied at all.The surgery was being proceeded by mipo method.The sales rep told the surgeon that the 2nd hole from the distal end may have been damaged.The skin incision was enlarged, and direct visual inspection revealed that the hole was indeed broken.Screw insertion into the hole in question was abandoned, an mpt plate was added medially to fix the affected area, and the surgery was completed successfully within 30 minutes delay.Patient status/ outcome, stable.No further information is available.This report is for one (1) unk - plates: proximal tibia plate this is report 3 of 3 for complaint (b)(4).

• Brand Name: UNK - PLATES: PROXIMAL TIBIA PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18595047
• MDR Text Key: 333961952
• Report Number: 8030965-2024-01427
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/29/2024
• 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: CORTSCR ø3.5 SELF-TAP L40 TAN; LOCKSCR ø3.5 SELF-TAP L38 TAN; UNK DRILL GUIDE
• Patient Outcome(s): Required Intervention