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

Model Number	03.240.002
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cannulated stardrive screwdriver (part # 03.240.002, lot # h082473, mfg # 09-aug-2016) was received with the distal tip twisted.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.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 # 03.240.002, synthes lot # h082473, supplier lot # na, release to warehouse date: 09 aug 2016, manufactured by synthes (b)(4), no ncr's 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 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 the evening of march 12, 2019, the sales consultant contacted field stocking location to say that the cannulated stardrive screwdriver shaft on set fe45498 was bent.The set was to be used in surgery on march 13, 2019.The replacement set was sent prior to surgery.There was no patient involvement.This report is for one (1) cannulated stardrive screwdriver shaft/t15 this is report 1 of 1 for (b)(4).

• Brand Name: CANNULATED STARDRIVE SCREWDRIVER SHAFT/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: 8574874
• Report Number: 2939274-2019-57793
• Device Sequence Number: 18903285
• Product Code: HXX
• UDI-Device Identifier: 10886982077523
• UDI-Public: (01)10886982077523
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 04/23/2019

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: 03.240.002
• Device Catalogue Number: 03.240.002
• Device Lot Number: H082473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1