MAUDE Adverse Event Report: SYNTHES GMBH T25 STARDRIVE SHAFT F/MATRIX STANDARD; SCREWDRIVERS

Catalog Number	03.632.002
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was received on 12/06/2020.Report source: updated.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that during a posterior spinal fusion performed on (b)(6) 2020, the surgeon felt something different from usual manner during screw insertion.As surgeon was inserting the screw, he heard little noise, and he finally found that the threads of the sleeve had chipped.He confirmed visually and by x-ray that no fragment was left in the patient¿s body.The procedure was completed with less than thirty (30) minutes surgical delay.Patient outcome is reported as stable.Concomitant device reported: locking/set screw (part # unknown, lot # unknown, quantity 1).This complaint involves two (2) devices.This report is for (1) t25 stardrive shaft f/matrix standard.This report is 1 of 1 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.H3, h4, h6: part: 03.632.002.Synthes lot: 6977039.Supplier lot: na.Release to warehouse: november 02, 2012.Manufactured by synthes monument.No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual investigation: the received screw driver shaft t25 is in a used and worn condition.Especially the tip, some of the t25 peaks are worn and slightly deformed.Investigation conclusion: after a visual inspection per guidance, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.End of life definition per important information leaflet, limits on reprocessing: end of life of a device is normally determined by wear and damage due to use.Evidence of damage and wear on a device may include but is not limited to corrosion (i.E.Rust, pitting), discoloration, excessive scratches, flaking, wear and cracks.Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used.No manufacturing related issue was identified and/or confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is appropriate.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: T25 STARDRIVE SHAFT F/MATRIX STANDARD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11036867
• Report Number: 8030965-2020-09866
• Device Sequence Number: 1023390
• Product Code: HXX
• UDI-Device Identifier: 07611819378063
• UDI-Public: (01)07611819378063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 03.632.002
• Device Lot Number: 6977039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 12/06/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RETAIN-SLEEVE STD F/MATRIX 5.5; UNK - LOCKING/SET SCREWS; RETAIN-SLEEVE STD F/MATRIX 5.5; UNK - LOCKING/SET SCREWS