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

Catalog Number	352.311
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.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
While performing an initial anterior cervical disc fusion at levels c4-c6, on (b)(6) 2017, the surgeon was tightening a screw in the vectra plate system when the screwdriver tip broke off.The fragment was retrieved quickly, and another screw driver was used to finish the case.There was no delay or harm to the patient.Concomitant device reported: screw (part number unknown, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: part 352.311, lot 9815148: release to warehouse date: july 06, 2015.Supplier: (b)(4).Manufacturing site: (b)(4).No non-conformance reports were generated during production.Review of the device history record (dhr) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A product investigation was completed: the returned extraction was inspected at customer quality and the complaint was confirmed.Upon visual inspection, it was noted that two (2) of the four (4) lobes had broken off the driver tip.The broken fragment was returned.It was noted that the outer sleeve of the device was not returned, so the lot number was not able to be visually confirmed.No new malfunctions were noted.Dimensional analysis was not performed as relevant features are significantly deformed.Whether this complaint could be replicated is not applicable because the device was returned broken.Dhr review was conducted on the reported lot and no non-conformance reports were generated during production.Material and hardness were tested at the time of manufactured and confirmed to have no issues through the dhr review.The relevant drawings were reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended.While no definitive root cause could be determined it is possible that the device encountered unintended torque forces leading to deformation and breakage.During the investigation, no product design issues or discrepancies were observed that may have contributed to the 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: 7155019
• Report Number: 2939274-2017-50498
• Device Sequence Number: 1988419
• Product Code: HXX
• UDI-Device Identifier: 10705034714578
• UDI-Public: (01)10705034714578(10)9815148
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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 Catalogue Number: 352.311
• Device Lot Number: 9815148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 82