MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CANNSCR Ø3.5 SELF-DRILL L40/12 TAN; SCREW, FIXATION, BONE

Catalog Number 405.440

Device Problem Dull, Blunt (2407)

Patient Problem No Code Available (3191)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.510k#: unknown device is not distributed in the united states, but is similar to device marketed in the usa.Device malfunctioned intra-operatively and was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4) used for: surgical intervention, the complaint indicated that the screw had difficulty advancing during implantation requiring additional surgical intervention and that the screws appeared to be round-tipped rather than self-drilling with cutting flutes.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history records review was requested.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.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 on an event in (b)(6) as follows: it was reported, that during a surgical case using the dens access system, the surgeon choose to insert a 40mm long dens screw.The near cortex was opened with a countersink so the screw advanced at first without any problem.As the screw neared the far cortex, the screw had difficulty advancing.It was noticed in the x-ray that the screw was round-tipped rather than self-drilling with cutting flutes as is supposed to be.Determining that this was the problem, it was suggested to the surgeon that a 38mm screw, which although a bit shorter, it was the only truly self-drilling screw in the caddy.The operation was completed successfully.The surgeon did not object, however, he did express some difficulty with the screw insertion.After the surgery, the selection of screws in the set were reviewed and determined that, all the screws were of the correct part number, however, they were all round-tipped rather than with sharp cutting flutes.There were no patient consequences.The action taken for procedure were that the surgeon selected a shorter screw than desired, though satisfactory, which was self-drilling with cutting flutes.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A device history record review was performed for the subject device: part number: 405.440.Synthes lot number: 9094500.Release to warehouse date: 02.Sep.2014.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.An investigation was performed for the subject device: it was reported that during a surgical case using the dens access system, the surgeon chose to insert a 40mm long dens screw.The near cortex was opened with a countersink so the screw advanced at first without any problem.As the screw neared the far cortex, the screw had difficulty advancing.As the salesperson present in the surgery, i noticed in the x-ray that the screw was round-tipped rather than self-drilling with cutting flutes as is supposed to be.Determining that this was the problem, i suggested to the surgeon that he use the 38mm screw, which although a bit shorter, it was the only truly self-drilling screw in our caddy.The operation was completed successfully.The surgeon did not complain per say, however, he did express some difficulty with the screw insertion.After the surgery, i reviewed the selection of screws in the set and determined that, in fact, all the screws were of the correct part number, however, they were all round-tipped rather than with sharp cutting flutes.The sales rep of israel has forwarded the problem directly to the group manager of spine sustaining engineers (benno niedermann) here the statement of his investigation during incoming of the complaint.These screws have been produced in the past in two different designs.Both were released and ce marked.The mathys design has 2 cutting flutes , the stratec design 3.Not just the number but also the shape of the cutting flutes are different.Since early last year, only the former stratec design is still available.Implants of the range 405.428 ¿ 405.450, are all self-drilling with the tip design according to the attached drawing.There is only one design left after the harmonization.If your surgeon does not like the tip of the old screw design, he could order new ones and exchange the old ones.The other way around is not possible anymore as the self-tapping screws do not exist anymore.The design and clinical risk management (dcrm) document was reviewed and found to adequately address the harm of this complaint condition.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.The narrative of the complaint could be confirmed due to the received picture.Device used for treatment, not diagnosis.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Corrected data: date of report, pma/510k: the incorrect date was inadvertently utilized in previous initial medwatch.The correct date is 3/5/2018.Reporter¿s facility name is unknown; it was reported inadvertently as ¿ ministry of health¿ on the initial medwatch report.Initial reporter occupation; labeled for single use 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

Further it was reported that the surgery was delayed for approximately 15 minutes in order to trying to advance the screw before choosing to change the screw.

• Brand Name: CANNSCR Ø3.5 SELF-DRILL L40/12 TAN
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7392385
• MDR Text Key: 104192961
• Report Number: 8030965-2018-52689
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819064690
• UDI-Public: (01)07611819064690(10)9094500
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405.440
• Device Lot Number: 9094500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention