MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RETRACTOR FRAME CRANIAL/CAUDAL

Catalog Number	03.615.100
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 one (1) retractor frame cranial/caudal from a synthes frames and handles caddy does not hold position and it slowly slips/ gives over time.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: lot number, date returned to manufacturer, date of manufacture.Subject device has been received and is currently in the evaluation process.Corrected data: no patient involvement was reported.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.
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.H10 additional narrative: device history review (dhr): part number: 03.615.100; synthes lot number: t125203; release to warehouse date: 12-may-2016; manufacture site: tuttlingen; part expiration date: n/a; list of nonconformance¿s: n/a.A review of the device history records showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.No ncrs were generated during the production of this device.A review of the device history records showed that there were no issues at the time of manufacturing of this device that would contribute to the complaint condition.Investigation summary: the following investigation flow was performed: device interaction/functional.Visual inspection performed at customer quality (cq) was able to confirm the condition of loosening/slipping, which does agree with the reported complaint condition.Visual inspection revealed that the screw that secures the wingnut has backed out slightly (approximately 1.0mm) and is causing the reported complaint condition.The returned device was assembled and the reported loose/slipping condition was able to be replicated.Therefore, this complaint is confirmed.The returned device was manufactured in may 2016.A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.No ncrs were generated during the production of this device.The retractor frame cranial/caudal (03.615.100) is a component of the insight access retractor set (01.615.100).The insight access retractor system allows for access for decompression and fusion through a minimally invasive approach.In use the retractor frame is assembled with the appropriate retractor blades (03.615.300-490), inserted into the incision and expanded to gain access.Finally the frame can be attached to a flex arm/table mount.No product design issues or discrepancies were observed.A dimensional inspection relevant to this complaint could not be performed because of the assembled condition of the device (the screw has backed out slightly however is still fixed to the device/could not be completely removed for analysis).A definitive root cause for the screw backing out could not be determined.It is most likely that attempted disassembly / removal of the screw occurred at sterile processing when the screw is not intended to be removed for processing.The loosened screw is causing a wobble effect reducing the effectiveness of the pinion gear.This complaint is confirmed however no product design issues or manufacturing discrepancies were identified during this 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: RETRACTOR FRAME CRANIAL/CAUDAL
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7504919
• Report Number: 2939274-2018-52141
• Device Sequence Number: 16648723
• Product Code: GAD
• UDI-Device Identifier: 10705034715360
• UDI-Public: (01)10705034715360
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.615.100
• Device Lot Number: T125203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 05/14/2018; 06/15/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/04/2018; 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1