MAUDE Adverse Event Report: ACUMED, LLC Ø1.1 X 150MM GUIDE WIRE, SINGLE TROCAR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 35-0029

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturing and inspection records were reviewed for t8 cannulated stick fit hexalobe driver (part number 80-4155, batch number 589808) and 20mm, 3.5 mini acutrak 3® bone screw (part number 3052-35020, batch number 588944) and no anomalies were found.However, the manufacturing and inspection records for ø1.1 x 150mm guide wire, single trocar (part number 35-0029) could not be reviewed as devices batch/lot number is unknown.The 3 returned devices were examined visually.T8 cannulated stick fit hexalobe driver (part number 80-4155, batch 589808) the driver tip showed several surfaces with visible, angled approximately 45-degree fracture planes relative to the driver's long axis.One remaining lobe portion was higher than all others.It also had a vertical fracture line in the valley of the lobe.These surfaces supported characteristics of a torsional failure pattern in a brittle material.The hardness of this driver tip measured approximately 54 or 53.5 hrc which indicates the heat treatment process correctly affected this part.This value resides lower than the print specification, 56 hrc, and most likely arises from an artifact of the testing location because this order's coupon passed the minimum hardness requirement.Furthermore, the value residing below the upper harness limit, 60 hrc, suggests the part was not overharden, which can potentially lead to increased embrittlement.The brittle fracture presentation resides consistent with the effects of the heat treatment process.The increased hardness provides the strength increase necessary to resist torsional loading during implant installation.20mm, 3.5 mini acutrak 3® bone screw (part number 3052-35020, batch number 588944) the returned screw showed marks consistent with the removal method described in the description of event and procedure completion.The tweezer marks are visible.The drive socket still retains part of the driver tip.Ø1.1 x 150mm guide wire, single trocar (part number 35-0029) the returned guide wire was visibly bent.It showed normal signs of being used in a surgical case, and the bent nature is consistent with the description of event and procedure completion.If the wire bent before or after the driver tip fractures is unknown.The driver tip's fracture patterns, marks on the returned screw and bent guide wire all support the commentary in the event description.However, based on the information received the root cause could not be determined.

Event Description

(2 of 3) it was reported during surgery, the surgeon inserted two (2).9mm wires.One wire as a de-rotational wire and the other wire as the guide wire for the acutrak3 mini screw.The surgeon drilled with the acutrak3 mini drill (part number 80-4142) with no reported indication of resistance across the fracture or the bone.The surgeon inserted a 20mm mini at3 screw with the t8 stickfit driver (part number 80-4155).While the surgeon was inserting the screw, without any reported measurable resistance, the surgeon turned the screwdriver, and the driver tip broke off in the recessed-head aspect of the screw.It was reported the surgeon said he felt no indication that the screw was stripping or that he should have been concerned about the driver tip possibly breaking.The surgeon was unable to get the pieces of the screwdriver tip out of the screw with a dental pick and had to use a needle driver to remove the screw.Subsequently, the surgeon had to reinsert the wire exactly where it was before and use a new screw to successfully complete the surgery.This issue prolonged the surgery by 20 minutes.No other adverse patient consequences were reported.This report is related to report number 3025141-2023-00739 and 3025141-2023-00741 for the other devices involved in this event.

• Brand Name: Ø1.1 X 150MM GUIDE WIRE, SINGLE TROCAR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 18379539
• MDR Text Key: 331377554
• Report Number: 3025141-2023-00740
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35-0029
• Device Catalogue Number: 35-0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Male