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

Catalog Number 03.615.100

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: manufacture date.Dhr review.Part number: 03.615.100, lot number: 991929.Date of manufacture: 25-jul-2014, 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 16 parts of the lot were checked 100% for critical features and for function at the final inspection on 07-jul-2014 and found to be conforming.An ncr # (b)(4) was started for all lots of sub component 208.0442 (right arm) produced to october 2014 due to the position of the pin on the tips.The nonconformance was addressed (no risk).The position of the pin on the top of the arm has no bearing on the positioning and the open state of the device.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
• Type of Device: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7062068
• MDR Text Key: 93222789
• Report Number: 9680938-2017-50002
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10705034715360
• UDI-Public: (01)10705034715360(10)T991929
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.615.100
• Device Lot Number: T991929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 12/27/2017
• Supplement Dates FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1