MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS TRANSVERSE CONNECTOR 40MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48551072
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during tightening of transverse cross connector bottom tabs broke off.This happened 8-10 times with all sizes of cross connectors.Proper technique was follow during tightened.
Additional Manufacturer Narrative
Method: visual inspection, material analysis, device history review, complaint history review, risk assessment; result: the device was confirmed visually to have fractured.Manufacturing records were reviewed and no manufacturing anomalies were reported.Materials analysis was performed and found that the observed fracture surface was found to have fractured in ductile overload.No material or manufacturing defects were found.Conclusion: the plausible root causes include:-excessive tightening torque applied, -previous damage to the clip during insertion.
Event or Problem Description
It was reported that; during tightening of transverse cross connector bottom tabs broke off.This happened 8-10 times with all sizes of cross connectors.Proper technique was followed during tightening.

• Brand Name: OASYS TRANSVERSE CONNECTOR 40MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6399638
• Report Number: 0009617544-2017-00092
• Device Sequence Number: 663270
• Product Code: KWP
• UDI-Device Identifier: 04546540596093
• UDI-Public: (01)04546540596093
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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
• Operator of Device: No Information
• Device Catalogue Number: 48551072
• Device Lot Number: 7BN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2017
• Supplement Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1