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

Model Number	314.27
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The large hexagonal screwdriver (p/n: 314.27, lot #: 4524144) was received at us cq.Upon visual inspection, it was observed that the handle of the complaint device was loose from the shaft.The shaft of the complaint device had broken at the pin support from inside the wooden handle, which allowed the handle of the device to appear loose, as it could detach from the shaft.The handles pin component was observed to be intact from the exterior of the device, meaning they were visible and flush with the handle surface.Both the broken shaft and handle were received at us cq.No other issues were identified with the returned components of the device.This complaint was confirmed as the device handle was loose due to broken shaft at pin support.Although no definitive root-cause can be determined, its possible that unintended forces were applied to the device.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 # 314.27, synthes lot # 4524144, supplier lot # na, release to warehouse date: 07 jan 2003, 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 an unknown date during an inspection, the shaft of the large hexagonal screwdriver was found to be loose.There was no patient involvement.This report is for one (1) large hexagonal screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: LARGE HEXAGONAL 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: 10554579
• Report Number: 2939274-2020-04211
• Device Sequence Number: 17028740
• Product Code: HXX
• UDI-Device Identifier: 10886982188731
• UDI-Public: (01)10886982188731
• 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): 09/02/2020

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: 314.27
• Device Catalogue Number: 314.27
• Device Lot Number: 4524144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1