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

Catalog Number	03.110.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: (b)(6).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: sep 11, 2014.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 procedure on (b)(6) 2017, the torque limiting attachment 1.2nm broke into two (2) pieces as the surgeon was backing out a screw from a plate.The age of the device is unknown.It was stated that the surgeon was applying the correct amount of pressure at the time of breakage.No pieces fell into the patient¿s wound and the procedure was completed successfully using an alternative device.There was no surgical time delay and the patient outcome was reported as stable.Concomitant devices reported: screw (part# unknown, lot# unknown, quantity 1), plate (part# unknown, lot# unknown, quantity 1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was performed on the returned subject device.The 03.110.002 lot number 1001817 1.2nm torque limiting attachment was returned and reported to have broken during surgery.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.This complaint is confirmed.The device does not appear to be broken into two separate pieces as reported.An internal component of the quick couple mechanism is broken causing the device to not function correctly though everything is retained and held together.This complaint condition was likely caused by over two years of consistent use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency.The 03.110.002 1.2nm torque limiting attachment is an instrument routinely used in the 2.4mm/2.7mm variable angle lcp forefoot/midfoot system per relevant technique guide.The device was manufactured in 9/2014 and is over two years old.The balance of the returned device is in fair condition with some discoloration near the etchings.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: 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: 6419554
• Report Number: 8030965-2017-11357
• Device Sequence Number: 539946
• Product Code: LXH
• UDI-Device Identifier: 10886982071828
• UDI-Public: (01)10886982071828(10)1001817
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/27/2017

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: 1001817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 04/24/2017
• 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 PLATE, QUANTITY 1; UNKNOWN SCREW, QUANTITY 1
• Patient Age: 29 YR