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

Model Number	03.816.013
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
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 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 (b)(4) 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) inner shaft for disc anchor instrument.This is report 4 of 4 for (b)(4).
Additional 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.Concomitant medical products updated.Dhr review was completed.Part: 03.816.013 , lot: 9450473, manufacturing site: haegendorf , release to warehouse date: 21.July 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 that the inner shaft, 03.816.013, was intact and showed only minor wear consistent with use.Functional testing showed that the inner shaft assembled and disassembled with the instrument for disc anchor blade, 03.816.012, as intended with no additional resistance.Thus, the received condition does not agree with the complaint condition ¿device interaction (2+ devices): unable to disassemble: rm¿ and the complaint condition could not be replicated.No definitive root cause was able to be determined as no functional issues or defects were identified with the returned device.The system risk document was found to adequately address the complaint condition.In conclusion, the complaint condition is unconfirmed as the device functioned with the returned mating instrument for disc anchor blade, 03.816.012, as intended.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
Concomitant medical products : 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) inner shaft for disc anchor instrument.This is report 4 of 6 for (b)(4).

• Brand Name: INNER SHAFT FOR DISC ANCHOR INSTRUMENT
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7463041
• Report Number: 2939274-2018-51932
• Device Sequence Number: 1007332
• Product Code: GAD
• UDI-Device Identifier: 10705034730691
• UDI-Public: (01)10705034730691
• 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,Followup
• 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: 03.816.013
• Device Catalogue Number: 03.816.013
• Device Lot Number: 9450473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement 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