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

Model Number 03.505.003

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Additional device product codes: dzj, hxx.Device is an instrument and is not implanted/explanted.Reporter is synthes sales consultant.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 during an unknown procedure on an unknown date, the surgeon used the matrixrib set to fix several rib fractures.During the case, the surgeon elected to use the 90-degree percutaneous driver set.These were the parts used from the set; one (1) turning handle for screwdriver, two (2) handle for screwdriver and two (2) shaft for screwdriver.The 90-degree drivers and shafts were acting like they were stripped out.One driver was still working decently.It was noted also that the surgeon indicated that the knob was turning on the 90-degree screwdriver, but the cruciform tip was not.An unknown screws were involved in the procedure but had no allegation.The driver was visualized as the surgeon was putting in the screw and it was still in contact with the screw head.There was an issue with the driver mechanism.The screwdriver had issues on several screws during this case.It was unknown if there was a surgical delay.There was no patient harm reported.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) shaft for 90° screwdriver.This is report 4 of 4 for complaint (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.Device evaluated by mfr, device manufacture date: device history records review was completed for part: 03.505.003, lot: 08172030.Manufacturing location: selzach, release to warehouse date: aug 10, 2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device evaluated by mfr: product investigation was completed.The shaft for the 90-degree screwdriver was received intact with no observed defects.Small amounts of an unidentified foreign material were noted within the bearings and on some teeth of the torque transmission gear on the inner shaft component.The transmission gear at the distal end of the outer shaft component also had small amounts of an unidentified foreign material.The shaft was assembled with the following returned mating parts: turning handle 03.505.005/lot: 8165481/quantity 1; handle 03.505.004/lot: 8172621/quantity 2.The shaft could be assembled with every combination of parts returned; when assembled with either returned handle and one turning handle, the gears of the shafts were able to be rotated smoothly as intended.No functional issues were noted with the any returned part.The device is also intended to disassemble for sterilization and was found to fully assemble and disassemble as intended.It was determined that the received condition does not agree with the complaint description for this device ¿ the complaint cannot be replicated with the returned device.Relevant drawings for the returned device was reviewed during the investigation.During the investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.The complaint condition was not replicated with investigation as the device functioned as intended.Although the finding of foreign material debris on the bearings and gear teeth had no impact on the functionality of the device during investigation, the complaint is considered confirmed with this finding.No design or manufacturing defect or deficiency was observed during the investigation.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown and the complaint condition could not be replicated.It is likely that improper sterilization and cleaning of the device over its lifetime of 1+ year led to this finding.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Corrected data: lot number.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: SHAFT FOR 90° SCREWDRIVER
• 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: 7903976
• MDR Text Key: 121565527
• Report Number: 2939274-2018-53930
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587013299
• UDI-Public: (01)10887587013299
• Combination Product (y/n): N
• PMA/PMN Number: K082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.505.003
• Device Catalogue Number: 03.505.003
• Device Lot Number: 08172030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 106