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

Catalog Number	03.615.100
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event reported only as 2017 device is an instrument and is not implanted/explanted.Initial reporter is synthes sales consultant subject device has been received and is currently in the evaluation process.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 a retractor frame cranial/caudal is not holding the retractor.The device will not stay open.The locking mechanism will not hold and the gear inside the device may be stripped.This was discovered in central sterile processing.There is no patient or procedure involvement.Concomitant devices reported: retractor (part number unknown, lot number: unknown, qty.1) this is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: manufacture date.Dhr review.Part number: 03.615.100, lot number: 951344 date of manufacture: 10-dec-2010, place of manufacture: tuttlingen.Description of dhr review: a review of the device history record from the manufacturing site tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications confirm that the components and final product met inspection records and certification.All 50 parts of the lot were checked 100% for important features and for function at the final inspection on 08-dec-2010 and found to be conforming.Two nr's were created.The first ncr an unconforming position of the pin on the arm (1,5mm instead of 1,0mm).The second ncr about unconforming groove near to the tip on the hudson connector.Both nonconformances were dispositioned uai by pd.Both non-conformances have no bearing to the complaint condition "device will not stay open".Customer quality conducted an investigation of the returned device.The retractor frame cranial/caudal ((b)(4)) is a component of the insight access retractor set ((b)(4)).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 ((b)(4)), inserted into the incision and expanded to gain access.Finally the frame can be attached to a flex arm/table mount.The returned device was examined and no defects or deficiencies were identifiable which could have contributed to the reported complaint condition.The retractor was able to be assembled, the sliding half was able to be moved forward and backwards on the fixed half and, when the toggle handle was placed in the lock position, the retractor formed a stable construct.As the complaint condition was unable to be replicated and no defects or deficiencies were identified which may have contributed to the complaint condition, the complaint is unconfirmed.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture): top-level.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is applicable as the complaint condition was unable to be replicated.A device history review, including material review, was performed for the returned instrument¿s lot number and no mrrs or complaint-related issues were identified with the lot number which may have contributed to the 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: 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: 7062979
• Report Number: 9680938-2017-50003
• Device Sequence Number: 118665
• Product Code: GAD
• UDI-Device Identifier: 10705034715360
• UDI-Public: (01)10705034715360(10)T951344
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

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: T951344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1