MAUDE Adverse Event Report: SYNTHES MONUMENT RATCHET T-HANDLE 6MM QC; SCREWDRIVERS

Catalog Number	03.632.090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2017
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.(therapy date): unknown.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: may 17, 2011.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 is reported during a procedure to remove a matrix spine construct on (b)(6) 2017, after successfully removing two (2) matrix locking caps, the surgeon attempted to remove a locking cap at l2 on the left, using a t-handle t25 stardriver shaft for matrix-long, but was not able to turn the locking cap.This attempt caused the stardriver shaft to bend close to the distal end of the instrument.The surgeon then attempted to loosen the locking cap using a ratchet t-handle with a t25 stardrive shaft for matrix-long.This stardrive shaft also became bent.The handle snapped as internal components broke, resulting in the handle spinning around the shaft and not turning the locking cap.Alternate techniques were attempted without success.The surgeon then loosened all remaining locking caps with no issue.The surgeon then returned to the locking cap that would not release.It was at that time it was noted the screw beneath the locking cap was loose in the bone.The surgeon was able to remove the screw and rod together with the locking cap using general instrumentation.It is not known if the screw was loose prior to surgery or if it became loose while surgeon was attempting to remove the locking cap.The surgery was delayed approximately five (5) minutes due to the reported issues but was completed successfully.Please see related complaint, com-(b)(4), which addresses and reports the need for the explant surgery.Concomitant devices reported: rod (part number 04.633.294, lot number unknown, quantity 1) this report is 3 of 4 for com-(b)(4).
Additional Manufacturer Narrative
A product development investigation was performed for the subject device (ratchet t-handle 6mm qc, part number 03.632.090, lot number 6599436).The subject device was returned with the complaint condition stating that the instrument could not remove the locking cap (09.632.009) from the polyaxial screw (04.632.540).The locking cap and polyaxial screw were not returned.The handle snapped as internal components broke, resulting in the handle spinning around the shaft and not turning the locking cap.The ratchet t-handle 6mm qc (03.632.090) is an alternative instrument utilized to insert polyaxial screws within the matrix degenerative and deformity systems per the technique guides.They are not listed as instruments intended to be utilized for locking cap loosening/removal.The following caution is noted: ¿never use fixed or ratcheting t-handle screwdriver for this technique.Per the technique guide, if the torque limiting attachment is not used when using any of the stardrive shaft options breakage of the driver may occur and could potentially harm the patient.¿ the relevant drawing for the returned instrument was reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of this device.A device history review was performed for the returned instrument¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.The complaint against the returned instrument was confirmed.The ratchet t-handle spun freely under both ratchet settings.As noted in the complaint description, the instrument was damaged while removing locking caps however the technique guide includes a note stating that a fixed or ratcheting t-handle screwdriver should never be used to remove locking caps.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RATCHET T-HANDLE 6MM QC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6366728
• Report Number: 1719045-2017-10157
• Device Sequence Number: 34534
• Product Code: HXX
• UDI-Device Identifier: 10705034719313
• UDI-Public: (01)10705034719313(10)6599436
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/02/2017

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: 03.632.090
• Device Lot Number: 6599436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• Supplement Report FDA Received Date: 03/01/2017
• 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: 04.633.294, 5.5MM TI HARD ROD 400MM, QTY 1
• Patient Age: 76 YR
• Patient Weight: 101