MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI LOW PROFILE NEURO SCREW SELF-DRILLING 3MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 400.833

Device Problems Break (1069); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received.(b)(6).Without a lot number the device history records review could not be completed.Investigation summary investigation selection: investigation site: (b)(4); selected flow(s): 5.Broken.Visual inspection: upon visual inspection: we have received seven (7) screws, three (3) 400.833 and four (4) 400.834, with no lot number reported/provided for investigation.Every screw has a broken off tip, just a bit of the shank is still visible on the screw head (we do not know where the missing parts are).Furthermore, all recess's show signs of usage, a few are even badly worn.This thus confirming the complaint description.Document/specification review: not required per selected investigation flow, as it is a post-manufacturing caused use related damage at the device.Dimensional inspection: not required per selected investigation flow, as it is a post-manufacturing caused use related damage at the device.Material or hardness review: not required per selected investigation flow, as it is a post-manufacturing caused use related damage at the device.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.Unfortunately, we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place or/and that during the operation excessive force (too much mechanical force whilst inserting into the bone) led to this damage.As these screws are very small and quite fragile, a lot of care is required while handling.We can confirm the visible damages are not from any manufacturing non-conformity.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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) 2018, during an unknown procedure, the seven (7) cranial screws got damaged while tapping.It was unknown if there was a surgical delay.Patient outcome was unknown.This report is for (1) ti low profile neuro screw self-drilling 3mm.This complaint involves seven (7) devices.This report is 3 of 7 for (b)(4).

Event Description

The procedure was successfully completed using another screw which was available in the set.There was no surgical delay.Patient outcome was good.Concomitant medical products: screwdriver (part: unknown, lot: unknown, quantity: 1).

Manufacturer Narrative

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: TI LOW PROFILE NEURO SCREW SELF-DRILLING 3MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8426608
• MDR Text Key: 139049253
• Report Number: 8030965-2019-62006
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819753440
• UDI-Public: (01)07611819753440
• Combination Product (y/n): N
• PMA/PMN Number: K031807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 03/18/2019
• Patient Sequence Number: 1