MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSTRUMENT FOR DISC ANCHOR; RETRACTOR

Model Number	03.816.012
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Date returned to manufacturer initial reporter is synthes sales consultant patient code (b)(4)-no code available used to capture change to surgical plan dhr review was completed.Part: 03.816.012 lot: 9450471 manufacturing site: (b)(4).Release to warehouse date: 31.July 2015 the device history record shows this lot of (b)(4) 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 instrument for disc anchor blade, 03.816.012, was assembled with the disc anchor, 03.816.330.Upon further inspection it was observed that the device 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 after which the knob on the proximal end of the device 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 device potentially leading to the over insertion functional inspection could not be performed as the instrument for disc anchor blade, 03.816.012, and the disc anchor, 03.816.330, could not be disassembled.The complaint condition is confirmed, agrees with the complaint condition of ¿device interaction (2+ devices): unable to disassemble : rm¿, and could be replicated as the devices could not be disassembled.During document/specification review the following drawings, reflecting the current and manufactured revision, were reviewed.Disc anchor instrument: 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 into the disc anchor blade.The system risk document was found to adequately address the complaint condition.In conclusion, the complaint condition is confirmed as the instrument for disc anchor blade, 03.816.012, and the disc anchor, 03.816.330, 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.
Event or Problem 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: knob for disc anchor instrument (03.816.014, lot l172936, quantity 1), third blade holder (03.816.004, lot 9275792, quantity 1), third blade holder (03.816.004, lot 9345894, quantity 1) this report is for one (1) instrument for disc anchor this is report 5 of 6 for (b)(4).

• Brand Name: INSTRUMENT FOR DISC ANCHOR
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7545666
• Report Number: 2939274-2018-52313
• Device Sequence Number: 177345
• Product Code: GAD
• UDI-Device Identifier: 10705034730684
• UDI-Public: (01)10705034730684
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.816.012
• Device Catalogue Number: 03.816.012
• Device Lot Number: 9450471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR