MAUDE Adverse Event Report: SYNTHES BETTLACH CANNULATED STARDRIVE SCREWDRIVER T15; SCREWDRIVERS

Catalog Number	03.226.041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A review of the device history records has been requested.Patient code (b)(4) used for: the tip broke intraop and an extension of the incision was performed to removed the broken tip.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 the patient underwent a triple arthrodesis of the ankle on (b)(6) 2017.During the procedure while the surgeon was placing two (2) 4.5 screws into the calcaneus, using a guide wire, the tip of the screwdriver broke off as the screws were being tightened manually.The reporter was unsure when the instrument malfunctioned, if it after the first or second screw placement.The fragment tip was easily retrieved although the incision line had to be enlarged to locate the fragment, that was discarded.A routine x-ray was taken that confirmed the fragment was retrieved.There was 5-10 minute delay.No harm was reported to the patient.Another similar instrument was available for the surgeon to place additional screws without difficulty.The procedure was successfully completed.The patient outcome was stable.This complaint involves 1 device.Concomitant devices reported: unknown screw, unknown part and lot numbers, quantity x 1 this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 03.226.041, lot# 2516961.Manufacturing location: (b)(4), manufacturing date: aug 19, 2009.No non conformance reports were generated during production.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.Product development investigation has been completed.A visual inspection, drawing review, and device history records review were performed as part of this investigation.The returned screwdriver was confirmed to have a broken tip.Three (3) of the screwdriver prongs tips were broken and the remaining three (3) were intact.The device has minor surface wear which does not impact functionality.Replication of the complaint condition is not applicable as the device is already broken.Relevant drawings were reviewed.No product design issues or discrepancies were observed.No definitive root cause was able to be determined.The broken tip is likely related to excessive torque.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: CANNULATED STARDRIVE SCREWDRIVER T15
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA CH254 4; SZ CH2544
• MDR Report Key: 6394113
• Report Number: 2520274-2017-10802
• Device Sequence Number: 18839699
• Product Code: HXX
• UDI-Device Identifier: 10886982077172
• UDI-Public: (01)10886982077172(10)2516961
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/15/2017

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: 03.226.041
• Device Lot Number: 2516961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREW, UNK PAR, LOT #, QTY. 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR