MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT Ø4.3 L413; FLUTED SURGICAL DRILL BIT, REUSABLE

Catalog Number 03.168.011

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/22/2022

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: this is report 3 of 3 for (b)(4).It was reported by the sales rep in (b)(6) that a patient underwent an open reduction internal fixation procedure for the fracture of the femoral neck on (b)(6) 2022.It was reported that during reaming by five mm minus to the measured value for a bolt, the reamer device cut out the femoral head.According to the surgeon, the bone quality was weaker than the surgeon expected, and the reamer pushed forward.It was reported that the surgeon drilled 90mm and inserted the antirotation-screw (90mm) after checking the image when the stopper was activated.However, the antirotation-screw was inserted about five mm inside of the drilling position, so that the surgeon replaced the antirotation-screw (90mm) with the antirotaion-screw (85mm).The surgery was completed successfully.The surgeon commented that he was aware that the position of the drilling was slightly shorter than the actual implant; however, the actual implant was longer than he had expected.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.This report is for one (1) drill bit ø4.3 l413 device.This complaint involves three (3) devices.

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.Without a lot number the device history records review could not be completed.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL BIT Ø4.3 L413
• Type of Device: FLUTED SURGICAL DRILL BIT, REUSABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 14159440
• MDR Text Key: 289611823
• Report Number: 8030965-2022-02537
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 07611819657373
• UDI-Public: 07611819657373
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.168.011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• 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