MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE; SCREWDRIVERS

Model Number	311.007
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is synthes sales consultant.A device history record (dhr) review was conducted: part# 311.007, synthes lot# 4572925, supplier lot# lm005356, manufactured by supplier s.S white medical products inc.Released to warehouse date: 02april2003.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was conducted.Visual inspection: the screwdriver handle with hex coupling-large was received assembled with 1.5mm/2.0mm screwdriver blade.Both device were found stuck/ locked, it was difficult to disassemble mating device.An excessive force was applied to disassemble mating device.Hence, the complaint is confirmed.Functional testing: once devices were dissembled, the sleeve of the returned device is able to move forward and back appropriately with no screwdriver blade inserted.The device was tested with a returned screwdriver blade.The sleeve was not moving as intended.The locking mechanism is rough running as it was not moving smoothly.There were some difficulties to assemble both of them.Also, it was creating difficulties in releasing but were able to be dissembled forcefully.The received condition does agree with the complaint description.The complaint can be replicated with the returned device(s).Dimensional inspection: internal diameter was measured at proximal and is with in specification per relevant drawings.Conclusion: the exact cause is unknown.We assume that after steam sterilization it may happen that the plastic bearing is swelling and therefore the movable sleeve can no longer be retracted, which may led to difficulties in mating and disassembling mating device.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.
Event or Problem Description
It was reported that during a routine field inspection on unknown date, one (1) screwdriver handle with hex coupling-large and one (1) screwdriver blade would not come apart from each other.One (1) low profile neuro compact module would not shut.There was no procedure and patient involvement.This report is for a screwdriver handle with hex coupling-large.This is report 2 of 2 for (b)(4).

• Brand Name: SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8533250
• Report Number: 2939274-2019-57587
• Device Sequence Number: 16603498
• Product Code: HXX
• UDI-Device Identifier: 10887587035604
• UDI-Public: (01)10887587035604
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/11/2018

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: 311.007
• Device Catalogue Number: 311.007
• Device Lot Number: 4572925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1