MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION; BIT,DRILL

Catalog Number 03.010.061

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 03/12/2020

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.(b)(4).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) 2020, the patient fractured the femoral trochanter (evans jensen classification: type ?).On (b)(6) the patient underwent open reduction internal fixation surgery for femoral trochanteric fracture with a tfna and the drill bit.After the surgery, the patient¿s affected limb inflamed, and the surgeon confirmed by angiography that the deep femoral artery was damaged.On the same day, (b)(6) 2020, the patient underwent revision surgery by coiling to the stop bleeding.The surgeon commented, with consideration to the distal locking position and the position of damage to the femoral artery, that it was possible that during the distal drill, the deep femoral artery was damaged with the drill bit.The bleeding of the deep femoral artery was stopped.The patient had chronic cardiac failure, chronic renal failure, parkinson disease, suspect of angioedema, prostatic hypertrophy and cataract.No further information is available.This report involves one (1) 4.2mm three-fluted drill bit qc/330mm/100mm calibration.This is report 1 of 1 for (b)(4).

• Brand Name: 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
• Type of Device: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9948197
• MDR Text Key: 193604093
• Report Number: 8030965-2020-02782
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819760899
• UDI-Public: (01)07611819760899
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Weight: 52