MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED STARDRIVE SCREWDRIVER T15; SCREWDRIVERS

Model Number	03.226.041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been 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
It was reported that on an unknown date, after the device came through decontamination, the cannulated stardrive screwdriver was noticed broken.There was no patient involvement.This report is for one (1) cannulated stardrive screwdriver t15.This is report 1 of 1 for complaint (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.A review of the device history record device history lot , part: 03.226.041, lot: 2387984, manufacturing site: bettlach, release to warehouse date: 30.July 2008.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary background: it was reported that on an unknown date, after the device came through decontamination, the cannulated stardrive screwdriver was noticed broken.There was no patient involvement.This complaint involves one (1) device.Flow: damage.Visual inspection: the investigation has shown that the tip of the screwdriver is broken off as complained.The complaint is confirmed.The broken off fragment was not returned for investigation.Document/ specification review a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Dimensional inspection: diameter of the shaft was measured just below the broken area.Outer diameter is, which comply with the specifications inner diameter could not be verified due to the post manufacturing damage.Investigation conclusion: although a definitive root cause could not be determined, it is possible that rough handling during use and/or processing could have contributed to the complaint condition.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: CANNULATED STARDRIVE SCREWDRIVER T15
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8687767
• Report Number: 2939274-2019-58592
• Device Sequence Number: 11355881
• Product Code: HXX
• UDI-Device Identifier: 10886982077172
• UDI-Public: (01)10886982077172
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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 Model Number: 03.226.041
• Device Catalogue Number: 03.226.041
• Device Lot Number: 2387984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1