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

Model Number	313.96
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: initial reporter is synthes sales representative.The cruciform screwdriver (part # 313.96, lot # l654292, mfg # 20-dec-2017) was received with the distal tip of the device twisted and one of the distal prongs severely bent.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional analysis was not performed as relevant features are significantly deformed.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being dropped, struck off axis or damaged during sterile processing).No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot, part: 313.960, lot: l654292, manufacturing site: (b)(4), release to warehouse date: 20.Dec.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 on (b)(6) 2019, during routine incoming inspection, a cruciform screwdriver was discovered as bent.There was no patient involvement.This report is for one (1) cruciform screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: CRUCIFORM SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8591766
• Report Number: 2939274-2019-57895
• Device Sequence Number: 2193027
• Product Code: HXX
• UDI-Device Identifier: 10887587037189
• UDI-Public: (01)10887587037189
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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: 313.96
• Device Catalogue Number: 313.96
• Device Lot Number: L654292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1