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

Catalog Number 530.705

Device Problems Output below Specifications (3004); Complete Loss of Power (4015); Excessive Heating (4030)

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

Event Date 01/01/2022

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 medwatch, a supplemental medwatch report will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).

Event Description

It was reported from (b)(6) that the battery reamer drill device could not be used because it was powerless and did not have enough energy to cut the bone.It was further reported that the device heated up and turned off when it was used for a while.According to the reporter when the device cooled down it could be used but could not cut the bone.It was not reported if the device was used in surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2022.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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: correction: upon further review of the complaint investigation, it was determined that the initially reported malfunction that the device could not be used because it was powerless and did not have enough energy to cut the bone and that the device heated up and turned off when it was used for a while was not confirmed.Therefore, an assignable root cause for the reported conditions of heat, will not run, insufficient/low power and device stops by itself was not determined.Subsequent investigation was performed and it was determined that the device was difficult to assemble/disassemble and only ran in reverse.

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.Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition that the device heated up was not confirmed.Therefore, an assignable root cause for the reported condition of heat was not determined.However, during evaluation, it was determined that the device only ran in reverse and would not run.It was further determined that the device failed pretest for check cannulation, check function of device, check forward/reverse mode function and check power with power test bench.The assignable root cause was determined to be due to component failure from wear.

• Brand Name: BATTERY REAMER/DRILL 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: 16066234
• MDR Text Key: 308444364
• Report Number: 8030965-2022-11612
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1