MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SLIP SLEEVE FOR THREADED HOLDING SLEEVE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.614.036
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part no.: 03.614.036, lot no.: 7552913: manufacturing location: (b)(4), release to warehouse date: 07.Nov.2011.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was performed.Parts were sent to sustaining engineering department for evaluation at investigational site a functional test was done with two synapse screws (art.No.04.614.232 / lot.No.7355313 and art.No.04.514.330 / lot.No.5501355).After assembling the three returned instruments according to the synapse surgical technique guide, the screwdriver could be attached to both polyaxial screws without any problems.A secure connection could be achieved and also removing the screwdriver could be done without any problems.Conclusion: the returned instrument passed the functional test without any problems.Therefore, a functional issue can be excluded.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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported patient underwent a posterior cervical spinal fusion utilizing the synapse system on (b)(6) 2018.After the hex screwdriver shaft, the threaded holding sleeve for polyaxial screw, and the slip sleeve for threaded holding sleeve were assembled, surgeon attempted to tighten a screw with the assembled unit, but the unit did not fit the screw.Surgeon immediately stopped using the assembled unit.Surgery was completed successfully with no delay and no adverse consequence to the patient.Surgeon stated the issue may have been due to cross-threading on the tip of the holding sleeve.This report is for one (1) slip sleeve for threaded holding sleeve.This is report 3 of 3 for complaint (b)(4).

• Brand Name: SLIP SLEEVE FOR THREADED HOLDING SLEEVE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7499400
• Report Number: 8030965-2018-53649
• Device Sequence Number: 14008798
• Product Code: LXH
• UDI-Device Identifier: 07611819964051
• UDI-Public: (01)07611819964051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.614.036
• Device Lot Number: 7552913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1