MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC GEAR COVER FOR SCREWDRIVER 90°; DRILL, BONE, POWERED

Model Number	03.505.007
Medical Device Problem Codes	Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record: device history lot: lot 8173333 was used for the finished shaft part 03.505.003.Therefore the mre was performed for the finished device: part: 03.505.003.Lot: 8173333.Manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: 27.Oct.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary background: it was reported that on an unknown date, during an open reduction internal fixation to the right ribs, the gear for screwdriver popped out of the backside of the shaft head when pressure was applied to the screwdriver blade.90¿ was being used to screw in a 12 mm screw during the procedure.When analyzed the gear itself seemed to be torn up from inner shaft engaging the threads.The gear was then reinserted and the cap was tightened onto the shaft again.Once repaired, pressure was again applied and the gear popped out of the backside again.The procedure was successfully completed with 15 minutes of surgical delay.Patient outcome is unknown.Concomitant device reported: unknown 12 mm screw (part#: unknown, lot#: unknown, quantity# 1), unknown screwdriver blade (part#: unknown, lot#: unknown, quantity# 1), unknown shaft (part#: unknown, lot#: unknown, quantity# 1).This complaint involves two (2) devices.Investigation flow: damage & device interaction/functional.Visual inspection: the gear cover for screwdriver 90° (p/n 03.505.007 lot 8173333) was received showing stripped threads.Functional inspection: functional testing could not be completed as only the gear (03.505.008) and gear cover (03.505.007) were returned.Per 90° screwdriver surgical technique (dsus/cmf/0117/0669 4/17), the gear is intended to be assembled onto the head of the shaft (03.505.003) and the gear cover is tightened onto the shaft with the gear using a turning handle (03.505.005).Not all mating devices for the 90° screwdriver were returned.The reported complaint condition could not be replicated as not all mating devices for the 90° screwdriver were returned.However, the gear cover for screwdriver 90° (p/n 03.505.007 lot 8173333) was stripped, which impacts the mating/assembly ability of the device.The device failure/defect of stripped threads was identified during the investigation and is related to the reported complaint condition.Dimensional inspection: dimensional inspection of the threads could not be conducted due to post manufacturing deformation of the threads.Document/specification review: the returned gear cover (p/n 03.505.007) was etched with lot 8173333, which corresponds to the shaft (p/n 03.505.003) of the assembled 90° screwdriver.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the gear cover for screwdriver 90° (p/n 03.505.007 lot 8173333) as the threads were stripped, which impacts the mating/assembly ability of the device.While no definitive root cause could be determined for the stripped condition, it likely due to normal wear from consistent use and/or rough handling.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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 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 open reduction internal fixation to the right ribs, the gear for screwdriver popped out of the backside of the shaft head when pressure was applied to the screwdriver blade.90¿ was being used to screw in a 12 mm screw during the procedure.When analyzed the gear itself seemed to be torn up from inner shaft engaging the threads.The gear was then reinserted and the cap was tightened onto the shaft again.Once repaired, pressure was again applied and the gear popped out of the backside again.The procedure was successfully completed with 15 minutes of surgical delay.Patient outcome is unknown.Concomitant device reported: unknown 12 mm screw (part#: unknown, lot#: unknown, quantity# 1), unknown screwdriver blade (part#: unknown, lot#: unknown, quantity# 1), unknown shaft (part#: unknown, lot#: unknown, quantity# 1).This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: GEAR COVER FOR SCREWDRIVER 90°
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8889753
• Report Number: 2939274-2019-59808
• Device Sequence Number: 3295058
• Product Code: DZI
• UDI-Device Identifier: 10887587013336
• UDI-Public: (01)10887587013336
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/17/2019

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: 03.505.007
• Device Catalogue Number: 03.505.007
• Device Lot Number: 8173333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/13/2019
• Patient Sequence Number: 1
• Patient Age: 31 YR