MAUDE Adverse Event Report: SYNTHES OBERDORF TORQUE LIMITING ATTACHMENT 1.2NM; MISC ORTHO SURGICAL INSTR

Catalog Number	03.110.002
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: 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: jun 17, 2016.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 torque limiting attachment came apart during a distal tibial ankle surgery on (b)(6) 2017.During the procedure, the torque limiting attachment, which was powered by a competitor¿s drill, came apart into three pieces and one spring.There was no report of breakage or fragmentation.The surgeon finished implanting the screws by hand.There was no surgical delay or patient harm.The procedure was successfully completed.The patient outcome was stable.Concomitant device reported: unknown competitor¿s drill (part# unknown, lot# unknown, quantity: one) this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was completed: this complaint is confirmed.Device was received disassembled in four (4) pieces.The spring, nose piece and collar are separate from the shaft and housing.No new malfunctions were identified.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.No non-conformance reports 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.The relevant drawing was reviewed during this investigation.No product design issues or discrepancies were observed.Unable to determine an exact root cause, but most likely the condition is due to mishandling.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: TORQUE LIMITING ATTACHMENT 1.2NM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• MDR Report Key: 6380871
• Report Number: 8030965-2017-11102
• Device Sequence Number: 18970757
• Product Code: LXH
• UDI-Device Identifier: 10886982071828
• UDI-Public: (01)10886982071828(10)1005479
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/09/2017

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: 03.110.002
• Device Lot Number: 1005479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• 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 COMPETITOR¿S DRILL, QTY 1