MAUDE Adverse Event Report: SYNTHES ELMIRA 2.8MM THREADED GUIDE WIRE-TROCAR POINT 300MM; APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM

Catalog Number 292.68

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2017

Event Type  malfunction  

Manufacturer Narrative

Patient weight is not available for reporting.Udi: (b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Without a lot number the device history records review could not be completed.Subject device has been received and is currently in the evaluation process.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.

Event Description

It was reported that on (b)(6) 2017, while removing a 7.3mm cannulated screw fully threaded due to a post-operative break of the implant, a guide wire was used to easily remove the previously implanted screw and was bent during use.To remove the broken screw fragments, the surgeon utilized a guide wire from synthes screw removal set.He ensured the screw fragments were aligned with the guide wire and inserted the guide wire through the two screw fragments in one motion.The guide wire passed through the bottom half of the screw but was inadvertently bent due to the angle required to pick up the second screw fragment.The first screw fragment was easily removed from the guide wire.When attempting to remove the second screw fragment, the surgical staff noted that the screw was stuck on the wire and that there was a bend in the wire making it difficult to separate the two devices.The screw was threaded tightly on the guide wire.At the back table the surgical staff attempted to separate the screw and the guide wire by malleting the screw from the bottom, up the length of the guide wire.The surgical staff continued to mallet and hammer at the screw up the length of the guide wire until the guide wire finally broke leaving a portion of the guide wire embedded in the broken screw fragment.Post-operative broken screw is addressed in (b)(4).This report addresses the guide wire issue.Concomitant devices reported: 7.3mm cannulated screw (part 209.670, lot number unknown, quantity 1).This report is for one (1) 2.8mm threaded guide wire.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed.The 292.68, lot number unk, 2.8mm threaded guide wire-trocar point 300mm was received with its broken tip fragment stuck in the proximal half of a broken screw.The tip of the guide wire protrudes approximately 13 mm from the breakage point of the proximal half.The length of the broken guide wire fragment is unknown since one end of the guide wire is stuck inside the cannulation of the broken screw.Replication of the complaint condition is not applicable as the device is already damaged.The concomitant part #: 209.670, lot #: unk, quantity: 1 was returned with an allegation against them captured in linked complaint (b)(4).The broken screw complaint condition is captured in (b)(4).A visual inspection under 5x magnification and drawing review were performed as part of this investigation.The 292.68 2.8mm threaded guide wire-trocar point 300mm is an instrument routinely used for precise placement and safety of cannulated instruments.The device was returned and the complaint condition is confirmed; the instrument was received with its broken tip fragment stuck in the proximal half of a broken screw.Although visually, the part cannot be seen as bent, it is stuck inside the broken screw, as reported: "the bend in the wire made it difficult to separate the two devices.Surgical staff continued to mallet and hammer at the screw up the length of the guide wire until the guide wire finally broke leaving a portion of the guide wire embedded in the broken screw fragment." the tip of the guide wire protrudes approximately 13 mm from the breakage point of the proximal half.The length of the broken guide wire fragment is unknown since one end of the guide wire is stuck inside the cannulation of the broken screw.The tip of the guide wire was also observed to be slightly beveled.It is unknown when this part was manufactured since the lot number is unknown.Although a definitive root cause could not be determined, this complaint condition is likely caused by excessive load/stress on the guide wire, causing deformation/bending.A dhr review was unable to be performed since the lot number is unknown.The latest revision of drawing was reviewed, since the manufacturing date is unknown, and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.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.

Manufacturer Narrative

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.

Manufacturer Narrative

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: 2.8MM THREADED GUIDE WIRE-TROCAR POINT 300MM
• Type of Device: APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6636374
• MDR Text Key: 77535631
• Report Number: 3003506883-2017-10110
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 292.68
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2017
• Initial Date FDA Received: 06/13/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/20/2017; 06/23/2017; 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 65