MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH FLEX ARM; MISC ORTHO SURGICAL INSTR

Catalog Number 03.612.010

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device is an instrument and is not implanted/explanted.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.(b)(4).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 patient underwent a procedure for lower back pain on (b)(6) 2018 utilizing the insight access retractor system.During the procedure, surgeon was not able to connect the flex arm bridge to the flex arm, as the screw on the flex arm did not turn to tighten the flex arm bridge.Surgery was completed successfully with a delay of approximately 30 minutes.No adverse consequence to the patient was reported.Patient status reported as stable.Concomitant devices reported: synframe flex arm bridge (03.612.012, lot number unknown, quantity 1).This report is for one (1) flex arm.This is report 1 of 1 for (b)(4).

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.Device history record (dhr) review: part number: 03.612.010; synthes lot number: h212060; supplier lot number: h212060; release to warehouse date: 01-feb-2017; supplier: mediflex surgical products; no ncrs were generated during production.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.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Supplier investigation summary: supplier: mediflex per the attached supplier product investigation; the investigator at mediflex was able to determine that the device was not operating as intended.Component 69580-syn-5 (starburst body) exhibited stripped threads due to excessive force preventing component 65052-syn (wing knob) to freely engage with its counterpart.Additionally, a review of the dhr shows that the device was manufactured and inspected to specification and functioned as intended upon departure from mediflex as shown on the attached documentation.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable.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: FLEX ARM
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7472797
• MDR Text Key: 106893017
• Report Number: 8030965-2018-53446
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819376403
• UDI-Public: (01)07611819376403
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.612.010
• Device Lot Number: H212060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1