MAUDE Adverse Event Report: SYNTHES BETTLACH CANNULATED HEX SCREWDRIVER F/6.5MM HDLSS COMPRESSION SCR; SCREWDRIVERS

Catalog Number	03.227.041
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.(b)(6).Device is an instrument and is not implanted/explanted.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture date: may 11, 2010.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 subtalar fusion revision (related complaint, (b)(4), addresses and reports the revision surgery) a screwdriver broke while removing of a 6.5mm headless screw on (b)(6) 2017.Fragments were generated but easily removed.Another screwdriver from the hospital¿s 6.5mm cannulated screwdriver set was used to finish the surgery with no surgical delay.The patient's outcome was stable.The procedure was completed successfully.Concomitant medical products: screw (part # unknown, lot # unknown, quantity 1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was completed: this complaint is confirmed.The distal hex tip has sheared off mid-hex feature.The fracture pattern is jagged.The sheared off tip fragment was not returned.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of this investigation.A visual inspection under 5x magnification, dimensional inspection of features related to this complaint, device history record (dhr) review and drawing review were performed as part of this investigation.The remaining hex features were measured and found to be within specification.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.The root cause is most likely due to excessive torsional force during screw removal of a screw with bony ingrowth which exceeded shear strength of this cannulated screwdriver tip.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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 HEX SCREWDRIVER F/6.5MM HDLSS COMPRESSION SCR
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6411634
• Report Number: 9612488-2017-10120
• Device Sequence Number: 674941
• Product Code: HXX
• UDI-Device Identifier: 10886982077240
• UDI-Public: (01)10886982077240(10)2595765
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/21/2017

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: 03.227.041
• Device Lot Number: 2595765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 04/17/2017
• 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 6.5MM HEADLESS SCREW, QUANTITY 1
• Patient Age: 64 YR
• Patient Weight: 113