MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BATT-HANDPIECE RECON SAGITTAL SAW W/T-HA; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.240

Device Problem Device Inoperable (1663)

Patient Problems Hematoma (1884); Swelling (2091)

Event Date 05/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 from (b)(6) that during a total knee replacement surgical procedure, it was discovered that the battery handpiece device jammed at the start of the first resection at the proximal tibial and eventually went dead.According to the reporter, it might have been due to a faulty internal connection as the battery device was in good working condition and fully charged.It was reported that the device was checked in the morning before the surgery started.It was reported that the malfunction caused the surgeon and the entire team to struggle to finish the procedure without the use of a heavy duty power saw device.According to the reporter, all of the cuts made were imperfect and it took a much longer time to shave and shape the bone for the trials.There was a one hundred and twenty minute delay to the surgical procedure.The reporter indicated that the surgery was completed with a spare device.It was reported that as the surgery time was prolonged, the patient who was under the tourniquet during the surgery experienced swelling on the operated leg and with severe hematoma.It was reported that the patient¿s stay in the hospital was also prolonged from one week to two weeks, and still counting.It was reported that the event caused the patient to have an unfavorable surgery outcome.There was patient involvement reported.There was medical or surgical intervention and prolonged hospitalization required as a result of this event.The patient's status post-surgery was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Upon subsequent follow-up with the customer, additional information was received.The reporter stated that the device oscillated the blade device correctly; however, when the blade device was placed against the bone, it was unable to oscillate.It was further reported that when the device was held away from the bone and was function tested in the air, the device was able to oscillate the blade device properly.According to the reporter, the oscillating vibration and the sound volume seemed normal; however, there was a mild or faint grinding noise that could be heard while oscillating.It was reported that when the device was once again placed against the bone, there was no oscillation, no sound, and no grinding noise.It was reported that when the device was pulled back from the bone, there was no oscillation and no sound from the device.The reporter indicated that an identical spare device was not available; therefore, a competitor¿s saw set was used.According to the reporter, when the surgeon tried to use the competitor¿s saw device to continue working with on the patient, the competitor¿s saw blade device was too thin and therefore, making it an incompatible option for use with the attune jig.The reporter stated that the blade device fitted properly with the attune jig, but the saw blade device was incompatible with the competitor¿s saw device.It was further reported that since the competitor¿s saw device was the only option to continue the tibial resection, the surgeon opted to manually perform the remaining cuts with the device.The reporter stated that since the length of the competitor¿s saw blade device was not long and thick enough, the resections made through the attune jig were not being resected precisely and so the surgeon had to visually measure the remaining cuts.It was reported that the patient did experience an infection.It was further reported that during the three weeks post-operation, the surgeon performed a tibial debridement and the attune tibial insert was replaced.It was reported that following the revision, the patient remained hospitalized and a patch of redness was present on the knee joint.According to the reporter, the patient was fifty-five years old female.The initial date of implantation was (b)(6) 2017, the revision was performed on (b)(6) 2017 and the operative site was the left knee.It was reported that two power module devices were used together with the device.It was reported that there were no alleged malfunctions against the devices.It was reported that the oscillating saw blade device.It was reported that the trauma recon system handpiece device was used for drilling, reaming, and pinning, but the sawing function could not be used as a saw attachment device was not available for use in the spare set.Additional devices that were used during this event has been included in the concomitant medical products section.Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition was confirmed.It was determined that the bearing was not functioning and defective.It was further determined that the needle bearing was blocked.It was further determined that the device failed pretest for check status of development, check for leakage, check falling out protection (steal ring), check the fitting of the lid, check function of all modes and check performance.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATT-HANDPIECE RECON SAGITTAL SAW W/T-HA
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6591685
• MDR Text Key: 76010771
• Report Number: 8030965-2017-12450
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.240
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR