MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 34MM; SCREW, FIXATION, BONE

Model Number	04.211.034
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent an unknown surgery.After the initial surgery, two screws came out on an unknown date, so a revision surgery was scheduled for and performed on (b)(6) 2022.No further information is available.This report is for a 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 34mm.This is report 6 of 7 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional procode: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: initial reporter is a synthes employee.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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part # 04.211.034s, lot # 4l50951, manufacturing site: (b)(4), release to warehouse date: 29 mar 2019, expiration date: 01 mar 2029, supplier: (b)(6).Non-sterile part # 04.211.034, non-sterile lot # h839068, manufacturing site: (b)(4), release to warehouse date: 21 feb 2019, supplier: (b)(6).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: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 34MM
• 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 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15438176
• Report Number: 8030965-2022-06953
• Device Sequence Number: 5595040
• Product Code: HWC
• UDI-Device Identifier: 10886982119094
• UDI-Public: (01)10886982119094
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.211.034
• Device Catalogue Number: 04.211.034S
• Device Lot Number: 4L50951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• 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 LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 TA.; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 TA.; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L24 TA.; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L34 TA.; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L34 TA.; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L36 TA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown