MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH HCS Ø3 SELF-DRILL CANN L22/8 TAN GOLD; SCREW,FIXATION,BONE

Catalog Number 04.226.122S

Device Problem Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 is not distributed in the united states, but is similar to device marketed in the usa.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation for distal humerus fracture, during the surgery the surgeon could not insert the headless compression screw completely.It was scheduled that the bone was pressed with the screw and fixed with a plate.The screw head was stripped when trying to bury it after inserting the screw shaft.The screw was removed and the bone was fixed with only the plate.The surgery was delayed by less than 30 minutes.The surgeon stated that the drill bit for the cortical bone is needed to insert the screw completely.No further information is available.Concomitant devices: unknown drill bits: trauma (part # unknown, lot # unknown, quantity # 1), unknown plates (part # unknown, lot # unknown, quantity# 1).This report is for one (1) hcs ø3 self-drill cann l22/8 tan gold.This is report 1 of 1 for (b)(4).

• Brand Name: HCS Ø3 SELF-DRILL CANN L22/8 TAN GOLD
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9202636
• MDR Text Key: 173325930
• Report Number: 8030965-2019-69396
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.226.122S
• Device Lot Number: 9812066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR