MAUDE Adverse Event Report: SYNTHES GMBH CORTSCR ø3.5 SELF-TAP L40 TAN; SCREW, FIXATION, BONE

Catalog Number	04.200.040TS
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem 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) cortscr ã¸3.5 self-tap l40 tan this is report 1 of 3 for complaint (b)(4).
Additional 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: d2b: additional product code: hrs d9: complainant part is not expected to be returned for manufacturer review/investigation.E1:(b)(6) general hospital.H3, h6: 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.
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.H4, h6 a manufacturing record evaluation was performed for the finished device product code: 04.200.040ts, lot number: 3160p66.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 09-dec-2022, manufacturing site:jabil grenchen, expiry date:01-nov-2027.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.

• Brand Name: CORTSCR ø3.5 SELF-TAP L40 TAN
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL GRENCHEN; solothurnstrasse 186; grenchen 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18595044
• Report Number: 8030965-2024-01423
• Device Sequence Number: 8024842
• Product Code: HWC
• UDI-Device Identifier: 10886982115799
• UDI-Public: (01)10886982115799
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131186
• 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,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.200.040TS
• Device Lot Number: 3160P66
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• 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: LOCKSCR ø3.5 SELF-TAP L38 TAN; UNK - PLATES: PROXIMAL TIBIA PLATE; UNK DRILL GUIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown