MAUDE Adverse Event Report: SYNTHES GMBH 3.2MM DRILL BIT/QC/195MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 310.290

Device Problems Failure to Cut (2587); Material Deformation (2976)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/26/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, it was noticed that the drills were blunt, the torque wrench was not working, and the wrench tips would not engage.The doctor reported that the issues with the devices caused an increase in surgical time and ligament injury in the patient.The patient was reported as stable.This report involves one (1) 3.2mm drill bit/qc/195mm.This is report 1 of 3 for (b)(4).

• Brand Name: 3.2MM DRILL BIT/QC/195MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12253531
• MDR Text Key: 264320214
• Report Number: 8030965-2021-06268
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2021
• 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
• Treatment: HANDLE FOR TORQUE LIMITER NOS. 511.770 AND 511.771; SCRDRIVER SHAFT 4.5/5 T25 SELF-HOLD F/AO; SCRDRIVER SHAFT 4.5/5 T25 SELF-HOLD F/AO
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR