MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM; BONE PLATE

Catalog Number 400.834S

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history lot: part: 400.834s.Lot: 3l17502.Manufacturing site: (b)(4).Release to warehouse date: 29.Jan.2019.Expiry date: 01.Jan.2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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) 2019, during the resection of cerebral arteriovenous malformation, the surgeon drilled the bone screw which did not screw into the skull.The screw was broken and the skull was damaged.It was then replaced with a new screw to complete the surgery.Concomitant device reported: unk - powered drivers/handpieces: trauma ( part # unknown, lot # unknown, quantity # 1);unk - plate (part # unknown, lot # unknown, quantity # 1).This report is for one (1) ti low profile neuro screw self-drilling 4mm.This is report 1 of 1 for (b)(4).

• Brand Name: TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
• Type of Device: BONE PLATE
• 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: 8965488
• MDR Text Key: 156620921
• Report Number: 8030965-2019-67988
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819771468
• UDI-Public: (01)07611819771468
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.834S
• Device Lot Number: 3L17502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - POWERED DRIVERS/HANDPIECES
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR