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

Catalog Number 530.705

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/13/2023

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.H10 additional narrative: d10.Concomitant med products and therapy dates: schantz screw device (13dec2023), jacobs's chuck device (13dec2023).D4, h4: the device serial/lot number and date of manufacture are unknown at this time.Udi - (b)(4).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 japan that during a total hip arthroplasty surgical procedure, a schantz pin/screw device, which is used for external fixation, was used with the battery reamer/drill device to remove the femoral head.When the schantz screw tip reached the center of the femoral head, the surgeon tried to stop the reamer by releasing his finger, but the trigger did not return, and the schantz screw continued to advance deep into the femoral head.It was reported that the surgeon managed to disconnect the connection and stop the schantz screw from advancing by randomly moving the connection between the reamer body and jacob¿s chuck.However, the tip of the schantz screw had already reached deep into the patient's acetabulum.It was reported that after the surgery, the patient had an mri and ct taken to check for any bleeding in the abdomen, and so far, there appears to be no problem.It was reported that there was no delay in the procedure due to the event.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.

• 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: 18382864
• MDR Text Key: 331201411
• Report Number: 8030965-2023-16063
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• 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?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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