MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM; SCREW, FIXATION, BONE

Catalog Number	04.130.210S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2023
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: e1: initial reporter is j&j company representative.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
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent orif surgery for third and fourth metacarpal fracture with screwdriver shaft, drill bit, va locking straight plate and locking screws.While the surgeon was drilling to fix the va locking straight plate, the drill bit broke.Fortunately, the drill bit could be removed from the body, and the surgery proceeded.Next, the screwdriver shaft broke when inserting the locking screw.But this one was also removed from the body.The surgeon proceeded with the surgery using a screwdriver of the same standard.After that, when inserting another locking screw, two screw heads broke.The surgeon removed one locking screw, but the other locking screw was inserted in a good position for fixation, so the surgeon left it in place and removed the implant.The surgeon then changed to 2.0mm plate and screw and fixed it, completing the surgery.All that remains in the patient¿s body is a single screw with a broken screw head.The surgeon thought the cause of the fracture was that the patient was 19 years old and had good bone quality.The surgery was completed successfully more than 180 minutes delay.No further information is available.This report is for one 1.5mm ti va-lckng scr slf-tpng with t4 stardrive recess 10mm for (b)(4).
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.H3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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.Lot number does not appear to be valid for this device, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.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.D10: date of concomitant therapy is (b)(6) 2023.

• Brand Name: 1.5MM TI VA-LCKNG SCR SLF-TPNG WITH T4 STARDRIVE RECESS 10MM
• Common Device Name: SCREW, 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: 17820410
• Report Number: 8030965-2023-12157
• Device Sequence Number: 11372716
• Product Code: HWC
• UDI-Device Identifier: 10886982112750
• UDI-Public: (01)10886982112750
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141527
• 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: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.130.210S
• Device Lot Number: 538P234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/07/2023
• 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: DRILL BIT ø1.1 L56/39 F/CORE HOLE; SCRDRIVER SHAFT 1.3/1.5 T4 SELF-HOLDING; VA LOCKING PLATE 1.5 12HO STRAIG L57 TI; VA LOCKSCR ø1.5 SELF-TAP L10 TAN; VA LOCKSCR ø1.5 SELF-TAP L10 TAN; VA LOCKSCR ø1.5 SELF-TAP L12 TAN; VA LOCKSCR ø1.5 SELF-TAP L12 TAN; VA LOCKSCR ø1.5 SELF-TAP L14 TAN
• Patient Age: 19 YR
• Patient Sex: Unknown