MAUDE Adverse Event Report: SYNTHES (U.S.A.) LP FLEXIBLE REAMING SET; REAMER

Model Number 351.48

Device Problems Break (1069); Device Tipped Over (2589); Battery Problem (2885); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 10/22/2020

Event Type  malfunction  

Event Description

Patient was being operated on for fractured femur.They used a reamer set that the shaft of the reamer is approximately 1/2" wide 17" long spring.The reamer was assembled correctly.The shaft was being reamed and the battery went low and the shaft got stuck.They changed the battery and then started to ream again, and the distal tip broke and within 2 seconds the proximal end broke.Per physician, "it was very old, and the spring shaft is an old design.Also, the battery was weak during reaming, jamming it." i was told they did make a distal incision in the bone to retrieve without success.Eventually, the surgeon was able to retrieve the two pieces thru the original incision.Reamer broke during the surgery necessitating additional reaming of the femur.The nail was seated, but would not traverse the isthmus of the femur due to the size of the nail, so it was carefully backed out, and decision was made to ream the canal, so that the nail would pass.This was carried out, and at the size 11.5 reamer, the battery on the drill died with the reamer stopping at the isthmus of the femur.A new battery was obtained, and when this was then used to start reaming again, the flexible shaft of the reamer broke off the tip of the reamer that held the actual 11.5 mm reamer head.Attempts were made at this point to back this out by backing up the ball-tipped guidewire, clamping it tightly and impacting the wire in a retrograde fashion and attempted back out the reamer and the broken reamer shaft, but this could not be done.It was clear that the 2 pieces together were jamming in the canal preventing it from backing up.Attempt was made to bring the wire out distally so that we could pull the reamer down with a separate ball-tipped guidewire, but could not retrieve the wire distally through a small hole in the femur that had been created with the 4.3 mm drill bit.Instead, a cannulated sleeve from the nail set was passed over the wire in an antegrade fashion, and this did reach down to the stuck broken reamer parts, and with direct tapping on this, i was able to drive the broken reamer and reamer head distal into the distal portion of the femur.Once this had been accomplished, then the femur could be reamed up to size 13 mm, which allowed for easy withdrawal of the broken reamer shaft and head.Canal was then irrigated at this point because this had taken longer than expected.After irrigating the canal, a new guidewire was placed back down the canal and confirmed to be in the correct position, and the gamma nail was passed to the correct height.The guidepin was then placed in the femoral head using the guide.Good fixation was noted.This was reamed, although the fracture was somewhat unstable, but care was taken not to malrotate the head, and the lag screw was seated with good fixation noted, and then, this was compressed back bringing the fracture, which had a basicervical component back to the shaft of the femur.The locking screw was placed, but allowed to slide, and then distally, a dynamic screw was used for the shaft.At this point, all the wounds were again irrigated, injected with marcaine, and closed with staples.The final fluoroscopic views were obtained, and the patient was then returned to the recovery room in stable condition.Facility has taken the tray out of service and are getting a loner set until they can determine replacement.

• Brand Name: FLEXIBLE REAMING SET
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES (U.S.A.) LP; 1302 wrights lane e; west chester PA 19380
• MDR Report Key: 11064624
• MDR Text Key: 223418138
• Report Number: 11064624
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/11/2020,12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 351.48
• Device Catalogue Number: 35148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2020
• Device Age: 25 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32120 DA
• Patient Weight: 72