MAUDE Adverse Event Report: SYNTHES MONUMENT FLEX ARM; MISC ORTHO SURGICAL INSTR

Catalog Number 03.612.010

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.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.Concomitant device therapy date is not known.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review, part number:03.612.010, synthes lot number: 9982802, supplier lot number: n/a, release to warehouse date: 14-jun-2016, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this 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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported the inside retractor does not hold the blades.Blades were not locking properly and were falling down.Issue was discovered prior to surgical procedure, no patient involvement.Concomitant devices reported: blade.This report is for one (1) flex arm.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Concomitant medical products: updated concomitant devices.Therapy date is unknown.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

Further it was clarified that 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.Concomitant devices reported: retractor frame, medial lateral (part # 03.615.002, lot # t126867, quantity 1), retractor frame, cranial caudal (part # 03.615.100, lot # t125713, quantity 1), holding sleeve ring (part # unknown, lot # unknown, quantity 1).

Manufacturer Narrative

The device has been received and the product evaluation is in progress.No conclusion can be drawn.Concomitant medical products: initially reported concomitant devices retractor frame, medial lateral (part # 03.615.002, lot # t126867, quantity 1), retractor frame, cranial caudal (part # 03.615.100, lot # t125713, quantity 1), are now considered as reportable devices and no longer considered as concomitant devices.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

This is report 2 of 4 for complaint (b)(4).

Manufacturer Narrative

Manufacturing evaluation was completed.Returned device was found to be fully functional and conforming with manufacturing specification.Additionally, a review of the dhr showed that the device was manufactured and inspected to specification and functioned as intended upon departure from mediflex.No manufacturing related issue was identified and/or confirmed.This complaint is unconfirmed.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.

Manufacturer Narrative

Additional narrative: customer quality conducted an investigation of the returned devices.We have forwarded the received two (2) flex arm (03.612.010 / 9982802), one (1) retractor frame medial lateral (03.615.002 / t126867) 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 03.612.010 / 9982802, 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.03.615.002 / t126867 and 03.615.100 / t125713, 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: FLEX ARM
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6894163
• MDR Text Key: 88454731
• Report Number: 1719045-2017-10982
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819376403
• UDI-Public: (01)07611819376403(10)9982802
• 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,Followup,Followup,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.612.010
• Device Lot Number: 9982802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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