MAUDE Adverse Event Report: SYNTHES HAGENDORF STRAIGHT TIP T15 DRIVER- STANDARD; SCREWDRIVERS

Catalog Number	03.632.055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Additional narrative: patient information not available for reporting.Device is an instrument and is not implanted/explanted.Concomitant devices: snap-on matrix transconnector: (item # unknown.Lot # unknown, quantity 1ea).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: 03.632.055/ lot # 8224862, manufacturing location: (b)(4), manufacturing date: 14.Jan.2013.No ncrs 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.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 the patient had original lumbar fusion surgery on an unknown date for an unknown reason.Patient was originally implanted with depuy expedium rods/screws at the l4-s1 disc level.Also one (1) snap-on synthes matrix cross link implant was used at the l4-l5 disc level.Patient had a follow-up procedure on (b)(6) 2017 to remove the original depuy expedium construct.Reason for the follow-up surgery is unknown.During the procedure, while the surgeon was instrument at the l4-l5 disc level and as he was removing the synthes snap-on matrix cross link transconnector implant with the straight tip screwdriver the tip of the screw driver instrument broke off into the head of the transconnector screw.The fragment was retrieved.Surgeon chose another screw driver from the instrument set that was available in the operating room.Patient was revised to new expedium screws/rod implants.There was no delay reported.Surgery was completed successfully and patient is reported in stable condition.This is for 1 device concomitant devices: snap-on matrix transconnector: (item # unknown.Lot # unknown, quantity 1ea).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation has been completed.A visual inspection, drawing review and dhr review were performed as part of this investigation.Breakage of the screwdriver tip was not confirmed; however it was confirmed that the tip was severely bent as a result of a counterclockwise force.Replication of the complaint condition is not applicable as the device is already damaged.The screwdriver tip is severely deformed in the direction of screw removal.Visual inspection does not show signs of tip breakage.The screwdriver was measured to be 173.78mm in length which is under the specification of 175mm +/- 1.The length being out of specification is likely related to the deformed tip.No other issues were noted during investigation.Relevant drawings were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The tip was likely bent due to excessive torque while attempting to remove a screw.Patient information not available for reporting.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: STRAIGHT TIP T15 DRIVER- STANDARD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6351586
• Report Number: 3003875359-2017-10082
• Device Sequence Number: 779737
• Product Code: HXX
• UDI-Device Identifier: 10705034719115
• UDI-Public: (01)10705034719115(10)8224862
• 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): 01/30/2017

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: 03.632.055
• Device Lot Number: 8224862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2017
• Supplement Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1