MAUDE Adverse Event Report: SYNTHES BETTLACH 3.5MM TORQUE LIMITING SCREWDRIVER/SELF-RETAINING; SCREWDRIVERS

Catalog Number	324.052
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: (b)(4).Device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture date: dec 6, 2008.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 a revision surgery was performed on (b)(6) 2107 due to a displaced fracture that occurred when the patient fell post-operatively.While using the 3.5 mm torque limited hand driver the surgeon was unable to get the head of the driver to seat securely in the recess of the locking screws.This in turn caused screws to feel as though the recess was stripped.Upon inspection of the tip of the hand driver, it did appear as though it was not uniform, and looked as though a replacement was in order.Another hand driver was available for use which had no additional surgical time added, and the procedure was completed without any complications.Patient status outcome was reported as positive.Please see related complaint (b)(4) which addresses and reports the need for revision surgery.Concomitant devices reported: unknown screw (part# unknown, lot# unknown, quantity 1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device (3.5mm torque limiting screwdriver/self-retaining, part number 324.052, lot number 2442691).The subject device was returned with the complaint condition stating: it was reported that a revision surgery was performed on (b)(6) 2107 due to a displaced fracture that occurred when the patient fell post-operatively.While using the 3.5 mm torque limited hand driver the surgeon was unable to get the head of the driver to seat securely in the recess of the locking screws.This in turn caused screws to feel as though the recess was stripped.Upon inspection of the tip of the hand driver, it appeared as though it was not uniform, and looked as though a replacement was in order.Another hand driver was available for use which had no additional surgical time added, and the procedure was completed without any complications.Patient status outcome was reported as positive.Concomitant devices reported: unknown screw (part# unknown, lot# unknown, quantity 1).This complaint is confirmed.The distal hex tip on the returned device is stripped (rounded/worn)) as reported.The distal hex edges show significant wear consistent with significant usage.The complaint condition was most likely due to cumulative wear over 8 years of field use for this self-retaining reusable instrument.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the distal hex tip on the returned device is already stripped (worn/rounded).A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The complaint condition was most likely due to cumulative wear over 8 years of field use for this self-retaining reusable instrument.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.5MM TORQUE LIMITING SCREWDRIVER/SELF-RETAINING
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6341189
• Report Number: 9612488-2017-10060
• Device Sequence Number: 11190035
• Product Code: HXX
• UDI-Device Identifier: 10886982191069
• UDI-Public: (01)10886982191069(10)2442691
• 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): 01/24/2017

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: 324.052
• Device Lot Number: 2442691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 03/23/2017
• 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, QUANTITY 1
• Patient Age: 64 YR