MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7MM TI VA-LCP T-FUSION PL/2 HOLE HEAD/LONG-STER; PLATE, FIXATION, BONE

Model Number	04.211.255S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
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.Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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 history part: 04.211.255s, lot no : 527p255, release to warehouse date: 19 nov, 2021, expiry date: 01 nov 2031, manufacturing site: (b)(4).Supplier : synthes usa hq, inc.A manufacturing record evaluation was performed for the finished article lot 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.
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 the right fifth metatarsal with the screw.After drilling with va drill sleeve when the surgeon tried to insert the screw with screwdriver, the screw could not locked.The surgeon commented that it was possible that the sleeve didn¿t hold the screw hole of plate and the insertion angle was over 15degree.The surgery was completed successfully without any surgical delay.Patient is listed as stable.Concomitant device reported: unk - guides/sleeves/aiming: trauma (part# unknown; lot# unknown; quantity: 1); unk - screwdrivers (part# 60.231.004; lot# unknown; quantity: 1).This is report 1 of 3 for (b)(4).This report is for a 2.4/2.7mm ti va-lcp t-fusion pl/2 hole head/long-ster.

• Brand Name: 2.4/2.7MM TI VA-LCP T-FUSION PL/2 HOLE HEAD/LONG-STER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15527597
• Report Number: 8030965-2022-07687
• Device Sequence Number: 6029040
• Product Code: HRS
• UDI-Device Identifier: 10886982119988
• UDI-Public: (01)10886982119988
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100776
• 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 Model Number: 04.211.255S
• Device Catalogue Number: 04.211.255S
• Device Lot Number: 527P255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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 - GUIDES/SLEEVES/AIMING; UNK - SCREWDRIVERS; VA LOCKSCR Ø2.4 SELF-TAP L18 TAN
• Patient Sex: Unknown