MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN; SCREW, FIXATION, BONE

Catalog Number	04.211.016TS
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).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.D9: complainant part is not expected to be returned for manufacturer review/investigation.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h6: lot provided is not a valid number, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.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
It was reported that on (b)(6) 2024, the patient underwent orif with a va-dhp plate for distal humerus fracture.In the process of drilling with sharp or wide angle to most distal screw hole on the plate, drilling and aimed screw were being air, the torque worked poorly, therefore, metal grinded objects were noticed.Once they were taken out, without wide angle condition, drilling to the same hole, the most distal screw one, was performed as retry for insertion, as a result, the torque well-worked.Intra-op image intensifier confirmed there is no the remainders in the patient¿s body.The surgery was completed successfully without any surgical delay.No further information available.This report is for one (1) va lockscr ã¸2.7 he 2.4 self-tap l16 tan this is report 1 of 2 for complaint (b)(4).

• Brand Name: VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN
• Common Device Name: SCREW, 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: 19321892
• Report Number: 8030965-2024-06270
• Device Sequence Number: 20417695
• Product Code: HWC
• UDI-Device Identifier: 10886982119001
• UDI-Public: (01)10886982119001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103243
• 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

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: 04.211.016TS
• Device Lot Number: 235L115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: VA-LCP DHP 2.7/3.5 DORSO-LAT W/SUPP-LAT
• Patient Sex: Unknown