MAUDE Adverse Event Report: SYNTHES BETTLACH LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE; SCREWDRIVERS

Catalog Number	314.13
Medical Device Problem Codes	Bent (1059); Material Distortion (2977)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part # 314.130; lot # 2418306; manufacturing location: (b)(4); manufacturing date: 11.Nov.2008.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that 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 a procedure, the sales consultant was viewing the instrument set and noticed that the tip of the hexagonal screwdriver with t-handle was twisted.The screwdriver was not needed for the procedure and had no bearing on the outcome of the procedure.The procedure was completed successfully.It is unknown as to when the tip became damaged.The tip is twisted and does not appear to be broken.This complaint involves one device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was performed.The 314.130 lot number 2418306 large hexagonal screwdriver with t-handle was returned.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.The 314.130 large hexagonal screwdriver with t-handle is an instrument routinely used in the screw removal set per relevant technique guide.The device was returned and reported to have a twisted tip.This condition is confirmed; the face of the distal hex tip is twisted around the perimeter of the hex in the direction of resistance from removal.It is likely that over eight years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition; however, this complaint is not likely a result of any design or manufacturing related deficiency.No new malfunctions were observed during the course of this investigation.The device was manufactured in 11/2008 and is over eight years old.The balance of the returned device is in fairly worn condition with several markings and signs of superficial wear.Relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.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: LARGE HEXAGONAL SCREWDRIVER WITH T-HANDLE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6434369
• Report Number: 9612488-2017-10132
• Device Sequence Number: 10958302
• Product Code: HXX
• UDI-Device Identifier: 10886982188571
• UDI-Public: (01)10886982188571(10)2418306
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2017

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: 314.13
• Device Lot Number: 2418306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1