MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN; SCREW, FIXATION, BONE

Model Number	04.211.020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent the open reduction internal fixation surgery for clavicle shaft fracture.In the surgery, the screw in question was broken.The distal portion of the plate was temporarily fixed with a k-wire, and the proximal portion was fixed with two locking screws.Then, since the reduction position was required to be corrected, he attempted to remove the second screw from the proximal position and the screw head was broken.The screw shaft has been left behind in the bone.The surgery was completed successfully by fixing the other hole without any surgical delay.He commented that he might not have handled the driver vertically.No further information is available.Concomitant detail: unk plate( part# unknown, lot# unknown, quantity# unknown).Unk - screwdrivers: shafts( part# unknown, lot# unknown, quantity# unknown).Unk - cable/wire( part# unknown, lot# unknown, quantity# unknown).This report is for one (1) va lockscr ã¸2.7 he 2.4 self-tap l20 tan, this is report 1 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j employee.Device is not distributed in the united states, but is similar to device marketed in the usa.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D4 h3, h4, h6: sterile part 04.211.020ts, lot 8l98420: manufacturing site: werk selzach.Supplier: (b)(4).Release to warehouse date: january 17, 2022.Expiration date: january 01, 2027.Non-sterile part 04.211.020, lot 585p169: manufacturing site: werk selzach.Supplier: (b)(4).Release to warehouse date: december 30, 2021.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 3035526892
• MDR Report Key: 15012535
• Report Number: 8030965-2022-04827
• Device Sequence Number: 6753187
• Product Code: HWC
• UDI-Device Identifier: 10886982119025
• UDI-Public: 10886982119025
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• 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 Model Number: 04.211.020
• Device Catalogue Number: 04.211.020TS
• Device Lot Number: 8L98420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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: UNK - CABLE/WIRE; UNK - SCREWDRIVERS: SHAFTS; UNKNOWN - PLATE
• Patient Age: 51 YR
• Patient Sex: Male