MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCRDRIVERSHAFT T25 CANN STD; SCREWDRIVERS

Catalog Number	03.632.003
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(4) as follows: it was reported that on (b)(6) 2019, the surgeon was performing a matrix mis spinal fusion and upon completion noticed that the standard t25 screwdriver shafts needed to be replaced.They were stripped at the distal end tip.The case was completed without delay and no patient incident occurred, therefore no patient information is available.This report is for one (1) scrdrivershaft t25 cann std.This is report 1 of 2 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.Initial report had incorrect report date.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
Product complaint # (b)(4).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.A review of the device history record.Device history lot part # 03.632.003, synthes lot # 6661058, supplier lot # na, release to warehouse date: 21 nov 2011, manufactured by synthes monument.Device history batch null, device history review review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Investigation summary background: dr.Peter jarzem was performing a matrix mis spinal fusion and upon completion i noticed that the standard t25 screwdriver shafts needed to be replaced given that they were stripped at the distal end tip.The case was completed without delay and no patient incident occurred, therefore no patient information is available.This probably happened due to wear and tear.I have no further details to add regarding this complaint.This complaint involves two (2) devices.Investigation flow: damage.Visual inspection: the scrdrivershaft t25 cann std (part # 03.632.003 lot # 6661058) was received at us cq.The distal threads of the screwdriver are twisted.The threads were twisted in the direction of resistance from insertion.The device¿s distal tip is slightly discolored and there are light surface scratches along the shaft.Both cosmetic issues are consistent with normal wear.The driver showed potential end of life indicators and normal wear from consistent/heavy usage during visual inspection.The received condition is consistent with the complaint condition thus the complaint is confirmed.Conclusion: after a visual inspection per guidance, it is determined that the reusable instrument is worn from repeated use and servicing (8+ years); 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.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: SCRDRIVERSHAFT T25 CANN STD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9157070
• Report Number: 2939274-2019-61203
• Device Sequence Number: 2802447
• Product Code: HXX
• UDI-Device Identifier: 07611819391468
• UDI-Public: (01)07611819391468
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2019

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: 03.632.003
• Device Lot Number: 6661058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 10/18/2019; 11/05/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 11/04/2019; 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1