MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION SCREWDRIVER; SCREWDRIVERS

Catalog Number	352.311
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient weight not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4) the screwdriver tip broke off in the screw.The surgeon was unable to remove the broken tip from the screw and had to use a different size screw to complete the surgery.This change in size of screw was a change in surgical plan.Device history records review was conducted.The report indicates that the: part # 03.613.004, synthes lot # 7735414, supplier lot # 7735414, release to warehouse date: 13 oct 2014, supplier: (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.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 an anterior cervical fusion, the surgeon was inserting a 4.0mm x 16mm variable angle screw using the removal driver, the tip of the inner shaft broke off into the screw head during an anterior cervical fusion.The surgeon got the screw (with inner shaft tip broken off inside the head) out of the patient/plate.The surgeon then replaced it with a larger diameter rescue screw (4.5mm x 16mm variable angle screw).There was no reported surgical delay.The broken tip was retained in the screw and retrieved.The entire screw was intact - no breakage of the screw.The procedure was completed successfully.The patient was reported as stable.Concomitant device reported: 4.0mm titanium cervical self-retaining screw, self-drilling/variable angle 16mm (part # 04.613.516, lot # unknown, quantity of 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
A product investigation was performed.The inner shaft for extraction screw driver (part: 03.613.004, lot: 7735414, mfg: 13-oct-2014) was inspected at customer quality and the complaint of broken was confirmed.Visual inspection performed at customer quality, observed that the distal portion of the inner shaft driver was broken.Broken fragments were not received.No new malfunctions have been identified.The returned device is sold as an assembly (part: 352.311, lot: 7735414) and the assembly shaft was not returned.Only inner shaft was received at customer quality.Whether this complaint could be replicated is not applicable as the device was returned damaged.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture and no design issues or discrepancies were noted.Dimensional analysis performed at the region proximal to breakage was measured and is found top be within the specification per relevant drawings.A device history review was performed for the returned instrument¿s lot number and no ncrs, mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Also, based on the device history record review, there is no indication that any issues with material or material properties contributed to the complaint condition.While no definitive root cause could be determined it is possible that any unintended forces encountered by the device during usage could have contributed to the complaint condition.During the investigation, no product design 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.A device history record (dhr) review was performed for part # 352.311, synthes lot # 7735414, supplier lot # 7735414: release to warehouse date: 13 oct 2014, supplier: (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.

• Brand Name: EXTRACTION SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7326087
• Report Number: 2939274-2018-50948
• Device Sequence Number: 10789049
• Product Code: HXX
• UDI-Device Identifier: 10705034714578
• UDI-Public: (01)10705034714578(10)7735414
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 352.311
• Device Lot Number: 7735414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 04/05/2018; 04/25/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/19/2018; 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR