MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CRUCIFORM SCREWDRIVER

Model Number	313.96
Medical Device Problem Codes	Crack (1135); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cruciform screwdriver (part # 313.96 / lot # 3605372) was received at us cq.The distal tip of the screwdriver was damaged as one blade was severely bent in the direction of tightening, while another blade was severely bent in the direction of loosening.Due to this damage, the drive feature can no longer be utilized.The handle was mildly cracked, the material had begun to raise from the handle.The received condition was consistent with the complaint condition thus the complaint was confirmed.The overall complaint was confirmed for the received cruciform screwdriver.Although no definitive root-cause can be determined its possible the device experienced unintended forces leading to the tip deformation and the handle crack.Based on the direction the blades deformed, it seems heavy rotational force (over-torque) contributed to the complaint condition.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history lot: part: 313.960, lot: 3605372, manufacturing site: (b)(4), release to warehouse date: 12.Nov.2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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.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, the reduction forceps with points rachet and synfix® evolution aiming were not functioning.A depth gauge for mini screws was obsolete and another depth gauge was also broken during reverse logistics inspection.There was no patient involvement and no additional information is available.This report is for one (1) cruciform screwdriver.This is report 2 of 2 for (b)(4).

• Brand Name: CRUCIFORM SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9644151
• Report Number: 2939274-2020-00527
• Device Sequence Number: 16679224
• Product Code: HXX
• UDI-Device Identifier: 10887587037189
• UDI-Public: (01)10887587037189
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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 Model Number: 313.96
• Device Catalogue Number: 313.96
• Device Lot Number: 3605372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1