MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN; SCREW, FIXATION, BONE

Catalog Number	04.211.018TS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
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: d2b: additional product code: hrs.D9: complainant part is not expected to be returned for manufacturer.Review/investigation.E1: (b)(6) hospital.H4, h6.Part # 04.211.018ts.Lot # 152l137.Manufacturing site: werk selzach logistik.Release to warehouse date: 15.March.2023.Expiration date: 01.March.2028.Supplier: früh verpackungstechnik ag.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.211.018.Non-sterile lot # 3033p06.Manufacturing site: werk selzach logistik.Release to warehouse date: 19.Nov.2022.Supplier: synthes usa hq, inc.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.
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 a surgery treating the right clavicle.The surgeon opened the screw and tried to connect the screw head to a t8 screwdriver, but the screw head could not be connected.The surgeon exchanged the screwdriver and tried to connect the screw to the new screwdriver, but he couldn¿t.The surgeon did not used the screw in question at the surgeon¿s discretion and used another screw with the same standard.The surgery was completed successfully with no surgical delay.Patient status/ outcome: stable.No further information is available.This report is for one (1) va lockscr ã¸2.7 he 2.4 self-tap l18 tan.This is report 1 of 1 for complaint (b)(4).

• Brand Name: VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 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: 17912696
• Report Number: 8030965-2023-12844
• Device Sequence Number: 7525790
• Product Code: HWC
• UDI-Device Identifier: 10886982119018
• UDI-Public: (01)10886982119018
• 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: 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 Catalogue Number: 04.211.018TS
• Device Lot Number: 152L137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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: UNK - SCREWDRIVERS.
• Patient Age: 34 YR
• Patient Sex: Male