MAUDE Adverse Event Report: SYNTHES TUTTLINGEN RETRACTOR FRAME MEDIAL/LATERAL

Catalog Number 03.615.002

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.(b)(6).A device history record (dhr) review was performed for part # 03.615.002, lot # t126867: manufacturing date: 23-aug-2016: a review of the device history record from the manufacturing site (b)(4) 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 15 parts of the lot were checked 100% for critical features and for function at the final inspection on (b)(4) 2016 and found to be conforming.No non-conformance reports (ncrs) were generated during manufacturing.A manufacturing investigation was performed.The device was returned in a very good condition, no visible damage.The manufacturing evaluation shows that there were no issues during the manufacture of the product that would contribute to this complaint condition.All critical dimensions of the device were checked and found to be conforming.No manufacturing issue was found during investigation.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the flex arms are not holding the retractor frames (cranial caudal and medial lateral).It is impossible to push the frames into the holding ring sleeve, something is blocking inside.This was detected before the surgery.No patient was involved.Concomitant device reported: holding sleeve ring (part # unknown, lot # unknown, quantity 1).This report is for one (1) retractor frame medial/lateral.This is report 3 of 4 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: customer quality conducted an investigation of the returned devices.We have forwarded the received two (2) flex arm ((b)(4)), one (1) retractor frame medial lateral ((b)(4)) and one (1) retractor frame cranial caudal (03.615.100 / t125713) to the responsible manufacturing site for investigation, as the function test with the four (4) received parts had failed.Both (b)(4), the manufacturing investigation completed by mediflex that show the device was returned fully functional and conforming to manufacturing specification.A dhr review was conducted as part of the investigation, and showed no issues.(b)(4) and (b)(4), the manufacturing evaluation shows that there were no issues during the manufacture of the product that would contribute to this complaint condition.All critical dimensions of the device were checked and found to be conforming.We have forwarded the received four (4) parts to the responsible sustaining engineering department in the usa for evaluation, as all parts meet manufacturing accuracy, here is the statement.We are aware of the flex arm connection issue.We have functionally tested the associated arms, and have documented the noticeable issue with the couplings, which was found on the returned arms.It has been determined that while the arms have been manufactured properly according to the mia and current drawing specifications, the tolerance of the drawing is such that it still leaves open the possibility of the arm not being able to mate with mating parts.Based on the results of the investigation, appropriate steps have been taken to resolve the design issue.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 MEDIAL/LATERAL
• Type of Device: RETRACTOR
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7033307
• MDR Text Key: 93039001
• Report Number: 9680938-2017-10142
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 07611819399846
• UDI-Public: (01)07611819399846(10)T126867
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.615.002
• Device Lot Number: T126867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• 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