MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR C 6MM INSERTER; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48328006
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/20/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the surgeon reported that there were 2 instruments damaged / broken in the kit.The customer further reported that the damage occurred with the surgeon was loading a cage on to the tip and that the thread where the cage attaches to the inserter tip is very thin and fragile and the surgeon snapped the thread whilst loading the cage.He then went to use the 6mm inserter tip and did the same thing again.The sales representative believes that the surgeon was checking the cage had been loaded correctly by trying to move the cage and snapped the thread again.The kit has been at the hospital for about 1 year and this surgeon has used this kit many times so is experienced with it.The 6mm and 7mm inserter tips are the sizes most commonly used in the set and the sales representative believes that they were in full working order before the case.The scrub nurse had managed to load the cage perfectly before the surgeon did.There was a slight delay in surgery approx.15mins.There was a spare 6mm inserter on the set which was used that to complete the surgery successfully.There was no adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The instrument was reported to be attached to the cage correctly, the stg was followed, was in the set for approximately a year and found to be in the field for 3 years based on manufacturing review.Conclusion: the product was confirmed to have the tip fractured.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.
Event or Problem Description
It was reported that; the surgeon reported that there were 2 instruments damaged / broken in the kit.The customer further reported that the damage occurred with the surgeon was loading a cage on to the tip and that the thread where the cage attaches to the inserter tip is very thin and fragile and the surgeon snapped the thread whilst loading the cage.He then went to use the 6mm inserter tip and did the same thing again.The sales representative believes that the surgeon was checking the cage had been loaded correctly by trying to move the cage and snapped the thread again.The kit has been at the hospital for about 1 year and this surgeon has used this kit many times so is experienced with it.The 6mm and 7mm inserter tips are the sizes most commonly used in the set and the sales representative believes that they were in full working order before the case.The scrub nurse had managed to load the cage perfectly before the surgeon did.There was a slight delay in surgery approx.15mins.There was a spare 6mm inserter on the set which was used that to complete the surgery successfully.There was no adverse consequences to the patient.

• Brand Name: ANCHOR C 6MM INSERTER
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5658152
• Report Number: 0009617544-2016-00188
• Device Sequence Number: 13497589
• Product Code: OVE
• UDI-Device Identifier: 04546540679147
• UDI-Public: (01)04546540679147
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K102606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2016

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: 48328006
• Device Lot Number: 137413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2016
• Supplement Report FDA Received Date: 07/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1