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

Model Number 03.505.008

Device Problem Material Twisted/Bent (2981)

Patient Problem Not Applicable (3189)

Event Date 01/01/2019

Event Type  malfunction  

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 for screwdriver 90° (p/n 03.505.008 lot unk) was received showing the tan plastic spacers severely worn, nicked, and chipped.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 plastic spacers could not be conducted due to post manufacturing deformation, and as the spacers cannot be disassembled from the gear.Document/specification review: the design of the gear (03.505.008) does not have a laser etch of the lot #, therefore, a dhr review for the returned part cannot be performed as the lot is unknown.However, the associated returned gear cover (p/n 03.505.007 under (b)(4)) was etched with lot 8173333, which corresponds to the shaft (p/n 03.505.003) of the assembled 90° screwdriver.A dhr review for the associated gear cover was performed and it was released to warehouse 27.Oct.2017.Therefore, the following drawing, reflecting the likely manufactured, and current revision, was reviewed.Gear kpl screwdriver 90° sm_120726 rev c 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 for screwdriver 90° (p/n 03.505.008 lot unk) severely worn, nicked, and chipped, which impacts the mating/assembly ability of the device.While no definitive root cause could be determined for the worn/nicked 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 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 2 of 2 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data-d4 lot unknown.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 FOR SCREWDRIVER 90°
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8889843
• MDR Text Key: 154315571
• Report Number: 2939274-2019-59811
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587013343
• UDI-Public: (01)10887587013343
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.505.008
• Device Catalogue Number: 03.505.008
• Device Lot Number: 8173333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Date Manufacturer Received: 08/15/2019
• Patient Sequence Number: 1
• Patient Age: 31 YR