MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TAP FOR 4.5MM OCCIPITAL SCREWS; TAP,BONE

Catalog Number 03.161.026

Device Problem Failure to Cut (2587)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 the occipito synapse system was used for a surgical procedure for cervical occipito fixation on (b)(6) 2019.There were no inconveniences for cervical fixation.However, at the time of performing occipucio fixation, through proper and reviewed technique by the medical team, it was not possible to carry out the fixation.The screws were not fixed, probably due to lack of edge of the male used.It was necessary to perform 11 perforations in the patient's skull, without achieving success with the technique described.An adequate perforation is not achieved, making the placement of the occipital screws impossible.Surgeon also tried with the male in cardan but the procedure was also not successful, because the doctor does not accommodate the angle of the instruments.Finally, the surgeon used screws of less diameter, achieved adequate drilling to finalize the fixation.The surgery lasted approximately 10 hours.This procedure does not last more than 5 hours.Patient outcome was reported as stable.Concomitant device reported: unknown occipital plate (part# unknown, lot# unknown, quantity unknown).Unknown rod (part# 04.161.030, lot# unknown, quantity 2).This report is for one (1) tap for 4.5mm occipital screws.This is report 1 of 10 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Background: the occipito synapse system was used for a surgical procedure for cervical occipito fixation.There were no inconveniences for cervical fixation.At the time of performing occipucio fixation, through proper and reviewed technique by the medical team, it is not possible to carry out the fixation, the screws were not fixed, probably due to lack of edge of the male used.It was necessary to perform 11 perforations in the patient's skull, without achieving success with the technique described.Finally, the surgeon used screws of less diameter, achieved adequate drilling to finalize the fixation.The surgery lasted approximately 10 hours.This procedure does not last more than 5 hours.Concomitant device reported: unknown occipital plate (part# unknown, lot# unknown, quantity unknown) unknown rod (part# 04.161.030 , lot# unknown, quantity 2).This complaint involves ten (10) devices.Investigation flow: device interaction/functional.Visual inspection: the tap f/cortscr ø4.5 l245 (part # 03.161.026 lot # u176896) was received at us cq.The tap had light surface scratches along the shaft that were consistent with wear.The cutting tip of the device was still sharp to touch.Magnification showed slight signs of wear as the proximal tips had some very small nicks.No other defects were identified.Functional test: the tap could not be tested as no relevant mating devices were returned.Based on the condition of the tip, it appears that the tap should be able to function as intended as the tip was still sharp to touch.Based on the event description it appears the tap was successful in tapping the holes.The overall complaint is not confirmed for the device as there appears to be no deficiencies with the tap.Can the complaint be replicated with the returned device(s)? no; no relevant mating devices were returned for functional testing.Manufacturing record evaluation: the received tap f/cortscr ø4.5 l245 (part # 03.161.026 lot # u176896) was manufactured at (b)(4).Three batches were released: batch 1: qty 33, released 10-jun-2013.Batch 2: qty 50, released 11-sep-2013.Batch 3: qty 43, released 29-oct-2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint was not confirmed for the received tap f/cortscr ø4.5 l245 (part # 03.161.026 lot # u176896) as the tip was sharp and should function as intended.There was no evidence of deficiencies with the returned tap.From the event description, it sounds like the tap was successful in tapping the holes and the used screws had issues.The only issues noted were light cosmetic issues that should have no impact on device functionality.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.H3, h4, h6: a review of the device history record.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety sign manufacturing location: orchid unique / final inspection and packaging by: monument release to warehouse date(s): 10-jun-2013 quantity 33, 11-sep-2013 quantity 50, 29-oct-2013 quantity 43 part number: 03.161.026, tap for 4.5mm occipital screws lot number: u176896 (non-sterile) lot quantity: 126 total (three batches; 33, 50 and 43) purchased finished goods travelers met all inspection acceptance criteria.Inspection sheets, incoming final inspection met all inspection acceptance criteria.Certificates of conformance received from orchid dated 23-may-2013 were reviewed and determined to be conforming.Specified hardness requirement was 50-55hrc; lots were certified at 51.66hrc.Packaging label logs lppf, lmd/lpf rev c (06-jun-2016 and 28-oct-2013) and ad (10-sep-2013) were reviewed and determined to be conforming.Note: the number of labels printed for each batch equaled the number of samples opened and/or the number of parts that needed to be repackaged.Packaging boms were reviewed and all components used met current, specified packaging requirements.This lot met all visual and packaging criteria at the time of release with no issues documented during the inspection, packaging or release that would contribute to this complaint condition.Device history batch null.Device history review 26-aug-2019:this lot met all visual and packaging criteria at the time of release with no issues documented during the inspection, packaging or release of the product that would contribute to this complaint condition.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: TAP FOR 4.5MM OCCIPITAL SCREWS
• Type of Device: TAP,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8975084
• MDR Text Key: 157044650
• Report Number: 8030965-2019-68087
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819871793
• UDI-Public: (01)07611819871793
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.161.026
• Device Lot Number: U176896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OCCIPUT ROD Ø3.5 TI; OCCIPUT ROD Ø3.5 TI; UNK - PLATES: SPINE
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 95