MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DISC ANCHOR BLADE 120MM FOR 3RD BLADE HOLDER; RETRACTOR

Model Number 03.816.320

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Patient weight not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).No code available used to capture change to surgical plan.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

It was reported that during an unknown surgery on (b)(6) 2018, the disc anchor blade was stuck on the anchor blade of an insight lateral access retractor system.The surgeon attempted to use a back up insight lateral access retractor system and experienced the same event where the disc anchor blade was stuck to the anchor blade of the insight lateral access retractor system.Since the two (2) retractors failed, the surgeon went with a competitor¿s retractor.The procedure was completed using the competitor¿s retractor to access the disc space, but the depuy synthes implants were still used as an inter-body.It was unknown if there was a surgical delay.As reported, the patient has been doing well.Concomitant devices reported: button for disc anchor instrument (part 03.816.015, lot unknown, quantity 1), instrument for disc anchor (part 03.816.012, lot unknown, quantity 1), knob for disc anchor instrument (part 03.816.014, lot unknown, quantity 1), third (3rd) blade holder (part 03.816.004, lot unknown, quantity 1).This report is for one (1) disc anchor blade for 3rd blade holder.This is report 2 of 4 for (b)(4).

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.Dhr review was completed.Part: 03.816.320.Lot: 9345402.Manufacturing site: haegendorf.Release to warehouse date: 14.Apr.2015.The device history record shows this lot of 24 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.The manufacturing documents were reviewed and no complaint related issues were found.Customer quality conducted an investigation of the returned device.Investigation flow: device interaction/functional visual inspection showed that the disc anchor, 03.816.320, was assembled with the instrument for disc anchor blade, 03.816.012, and the third blade holder, 03.816.004.When the interior button on the third blade holder is depressed the devices disassembled as intended.Thus, the third blade holder was confirmed as concomitant.Upon further inspection of the disc anchor blade and the mating instrument for disc anchor blade it was observed that the instrument for disc anchor blade is over inserted past the proximal edge of the blade in the disc anchor.It is probable that this condition has led to deformation of the dove tail feature on the mating surfaces of the two devices resulting in the stuck condition.The instrument for disc anchor blade, 03.816.012, is intended to assemble up to the proximal edge of the blade in the disc anchor, 03.816.320 after which the knob on the proximal end of the instrument is rotated to advance the blade.However, witness marks consistent with impact were observed on the concomitant knob, 03.816.014, which is consistent with forceful advancement of the instrument into the disc anchor potentially leading to the over insertion.Functional inspection could not be performed for the instrument for disc anchor blade, 03.816.012, and the disc anchor, 03.816.320, could not be disassembled.Functional inspection for the instrument for disc anchor blade, 03.816.012, and the third blade holder, 03.816.004, was completed and found to function as intended.The complaint confirmed is confirmed, agrees with the complaint condition of ¿device interaction (2+ devices): unable to disassemble : rm¿, and could be replicated as the instrument for disc anchor blade, 03.816.012, and the disc anchor, 03.816.320, could not be disassembled.During document/specification review the following drawings, reflecting the current and manufactured revision, were reviewed.Disc anchor: the design history was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Dimensional inspection of relevant features could not be conducted due to the inability to disassemble the devices.The insight lateral access system technique guide provides instruction on use of the device and assembly/disassembly of the construct.Based on the received condition, the probable cause of the issue was determined to be the over insertion of the instrument for disc anchor blade into the disc anchor blade.The system risk document was found to adequately address the complaint condition (action a-863894).In conclusion, the complaint condition is confirmed as the instrument for disc anchor blade, 03.816.012, and the disc anchor, 03.816.320, could not be disassembled.No design or manufacturing defect or deficiency was observed during the investigation.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.

• Brand Name: DISC ANCHOR BLADE 120MM FOR 3RD BLADE HOLDER
• Type of Device: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7463011
• MDR Text Key: 106587841
• Report Number: 2939274-2018-51928
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10705034731025
• UDI-Public: (01)10705034731025
• 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
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.816.320
• Device Catalogue Number: 03.816.320
• Device Lot Number: 9345402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR