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

Catalog Number 400.834S

Device Problems Crack (1135); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.(b)(6).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.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 an unknown date, during a closed cranial surgery, when the surgeon attempted to insert the screw, the screws threads were peeled/torn.It was related to different surgeons and different patients, as the hospital could not distinguish the specific information about surgeon, patient and specific event date.New screws were used to complete the surgery.There were no adverse consequences to the patient.Concomitant device reported: screwdriver (part number unknown, lot unknown, quantity 1).This report involves one (1) ti low profile neuro screw self-drilling 4mm.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: g3 h3, h6: part: 400.834s lot: 6l04907 manufacturing site: bettlach release to warehouse date: september 13, 2019 expiry date: september 01, 2029 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the cranial-scr plusdrive ø1.6 self-drill l4 was returned and received.Upon visual inspection, the threads were noticed to be damaged/stripped and the cross-slot feature was found to be visibly damaged amongst returned screws.The cross-slot feature may impact functionality with the mating screwdriver but does not directly affect material strength.Due to the severe cross slot damage, it appears there was an issue with the insertion of the screws.No other issues were identified with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed and no issues related to design and manufacturing were observed.- 1.6 mm cranial slf-drlg screw cruciform, low profile investigation conclusion the peeled/torn complaint condition was not confirmed for the cranial-scr plusdrive ø1.6 self-drill l4 however the threads were noticed to be damaged/stripped.The cross slots on the screw were also damaged.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The investigation found no evidence of a manufacturing defect or raw material issue.A root cause could not be determined during an investigation; however, it is possible the damage could be attributed to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H11 corrected data: d10 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 4MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10284005
• MDR Text Key: 199552664
• Report Number: 8030965-2020-04903
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819771468
• UDI-Public: (01)07611819771468
• Combination Product (y/n): N
• PMA/PMN Number: K022012
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.834S
• Device Lot Number: 6L04907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/11/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS