MAUDE Adverse Event Report: SYNTHES GMBH BATTERY RECIPROCATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.715

Device Problem Leak/Splash (1354)

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

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this, a supplemental report will be filed as appropriate.Udi: (b)(4).Lot/serial unknown.Device manufacture date: the device manufacture date is unavailable.The accounts full name, complete address and phone number were not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported from hong kong that during a total knee replacement surgical procedure it was observed that substances which are thought to be machine oil came out of the saw of the battery reciprocator device while the surgeon was performing a notch cut.It was reported that some substance came into contact with patient tissue.It was not reported if there was a delay in the procedure due to the event.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: b5: during subsequent follow-up with the reporter, additional information was obtained.The reporter stated that the surgeon tried to wash the oil substance off using the water gun, then he proceeded to the next step.The procedure was successfully completed.The status of the patient is unknown.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Udi - (b)(4).H10 correction: d4, h4: the device serial number was documented as unknown in the initial medwatch report.The serial number (b)(6) has been updated accordingly.The date of manufacture (dom) was documented as unknown in the initial medwatch report.The dom has been corrected to february 8, 2016.The udi has been updated accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Correction d9: please note that the product return date was inadvertently omitted in the previous medwatch report.Section d9 has been updated with this information.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device was returned for evaluation.Quality engineering evaluated the battery reciprocator device and the reported condition that substances which are thought to be machine oil came out of the saw of the battery reciprocator device while the surgeon was performing a notch cut was confirmed.The device was visually inspected, and it was found that the device passed visual inspection.During the assessment it was found that the device did not function.Due to this some of the test steps could not be performed.The device was disassembled, and it was found that the gear was stuck due to corrosion.The motor was tested after it was separated from the gear to confirm the motor was running and the problem was only caused by the gear.Inside of the device a brownish fluid was found which could be the liquid that was mentioned in this complaint.It was further determined that the device failed pretest for check the function of the device and check oscillation frequency with frequency meter.It was determined that the root cause for the found defect is linked to normal wear over time.This is supported by the general condition inside of the device.A review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.

• Brand Name: BATTERY RECIPROCATOR II FOR BPL II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 15919271
• MDR Text Key: 308158725
• Report Number: 8030965-2022-10662
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491854
• UDI-Public: 07611819491854
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• 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