MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T25/SELF-RETAINING QC 280MM; SCRWEDRIVER

Catalog Number	03.010.109
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.A review of the device history records has been requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on (b)(6) 2018, during a hardware removal, the unknown screwdriver broke while removing a screw.Another unknown screwdriver was used.There was no surgical delay.The procedure was successfully completed.Patient status is stable.Concomitant devices reported: unknown screw (part # unknown, lot # unknown, quantity # 1).This complaint involves 1 (one) device.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.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.Part: 03.010.109; synthes lot: h369588; release to warehouse date: august 23, 2017; manufacturing site: 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 subcomponents, which would contribute to this complaint condition.Visual inspection: the returned device was examined, and the distal threaded tip was found to be stripped.The observed damage is consistent with the reported complaint condition.As such, the complaint condition can be confirmed, however an analysis code of visual: stripped/worn/twisted/cross threaded better captures the observed failure.No further visual defects or deficiencies were noted.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.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: STARDRIVE SCREWDRIVER SHAFT T25/SELF-RETAINING QC 280MM
• Common Device Name: SCRWEDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8135763
• Report Number: 2939274-2018-55308
• Device Sequence Number: 14018726
• Product Code: HXX
• UDI-Device Identifier: 10886982067814
• UDI-Public: (01)10886982067814
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2018

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: 03.010.109
• Device Lot Number: H369588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 01/03/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/07/2019; 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1