MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T-15, LONG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T-15, LONG
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the tip of the ar-9545-t15-03, driver shaft, t-15 long broke in central screw head during an rtsa procedure.During the same procedure, the rep opened a package that was supposed to contain ar-9502f-39rcpc (lot: 1800369), but there was a 42+6 spacer inside the box instead.The rep confirmed that the 42+6 spacer was not used during the procedure.The rep had a back up ar-9502f-39rcpc that was available and used to complete the procedure.Additional information has been requested.Additional information received on 10/26/2018: the rep stated that the trinity guide was used for the central screw.The screw was inserted into the central hole correctly.The driver was used with the ar-9545-t15h, torque indicating adapter.The rep confirmed that the surgeon did not exceed the 5mm mark on the torque indicating adapter.The rep confirmed that the tip of the driver remains in the head of the central screw.The rep confirmed that there no attempts were made to remove the broken tip from the screw head.The case was completed by impacting enough of the screw to make to central checker show green.The rep confirmed that this was an initial surgery.The rep confirmed that the original packaging for the mislabeled ar-9502f-39rcpc (lot: 1800369) is available to return to arthrex.The rep stated that the package was labeled for an ar-9502f-39rcpc (lot: 1800369), but the package contained ar-9550-06 (lot: 17.01630).The rep stated that they had to leave the or to find another ar-9502f-39rcpc to use in the procedure.The rep stated that this issue caused approximately a five to seven minute delay in the procedure.

• Brand Name: DRIVER SHAFT, T-15, LONG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8065577
• Report Number: 1220246-2018-00742
• Device Sequence Number: 18886076
• Product Code: LXH
• UDI-Device Identifier: 00888867225176
• UDI-Public: 00888867225176
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DRIVER SHAFT, T-15, LONG
• Device Catalogue Number: AR-9545-T15-03
• Device Lot Number: 8001832
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other