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

Catalog Number 530.705

Device Problems Circuit Failure (1089); Intermittent Loss of Power (4016)

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

Event Date 02/24/2022

Event Type  malfunction  

Event Description

It was reported from (b)(6) that during a bipolar hemiarthroplasty (bha) surgical procedure it was observed that the battery reamer/drill device would work, and then would not work.The reporter stated that the device sometimes moved during use, sometimes stopped moving and sometimes stopped but starting to move.It depended on the luck of when the surgeon turned the device on.It was noted that a bad electrical contact was suspected.It was reported that there was no delay in the procedure due to the event.It was not reported if a spare device was available for use.It was reported that the procedure was successfully completed.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 medwatch will be submitted accordingly.

Manufacturer Narrative

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.Additional narrative: udi: lot/serial unknown.(b)(4).Device manufacture date: the device manufacture date is unavailable reporter's phone number was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

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: the unique identifier (udi) has been updated accordingly.Udi - ((b)(4).Correction: d4, h4: it was documented in the initial medwatch report that the date of manufacture (dom) and serial number was unknown.The dom (march 18, 2016) has been updated and the serial number ((b)(6)) has been updated.

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: the actual device was returned for evaluation.Quality engineering evaluated the battery reamer/drill device, and the reported condition that the device sometimes moved during use, sometimes stopped moving and sometimes stopped but starting to move was confirmed.An assessment was performed, and it was found that the device failed visual inspection.The device was received in optical heavily used condition.The electronic control unit (ecu) coating was vanishing, and the contacts showed beginning corrosion.Also, the ecu was covered with dents from normal wear over time.The battery reamer device passed all functional testing without failure however, the mode switch resistance was too low.It was noted that the received allegation could not be reproduced.It was determined that the reported failure resulted from either a defective battery casing or the device failed due to lack of maintenance service.The assignable root cause of these condition was determined to be traced to component failure due to wear.A review of the device history was performed and no non-conformances were detected related to the reported condition.

• 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 (Section G): WERK PT & C (CH)
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 13637244
• MDR Text Key: 289288663
• Report Number: 8030965-2022-01242
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491830
• UDI-Public: 07611819491830
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• 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: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2016
• 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