MAUDE Adverse Event Report: STRYKER SPINE-US ACCULIF TL TUBING SET; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	905103
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; we are unsure but it is possible that an expired box of tubing was utilized.The surgery date was (b)(6) 2017 and the expiration date on the tubing was 3/31/2017.This item was not in inventory in oracle to reserve as we only ever received 3 boxes per oracle and those 3 boxes were previously billed.We are not sure how/when we got this item however not it was not transacted in oracle to us and therefore was not on our expiration report.Since the item wasn't in oracle to transact and since the sales representative had 4 kits, one of which being a loaner, we waited for the kit to be counted upon return to see if another lot number was missing from that kit (and would be transferred into our inventory to bill) however loaners did not show any of the item missing from their loaner kit.Additionally, we asked the main sales rep at the account to do an inventory count to see what lot numbers were in the other kits in his possession to see if another lot number was missing and may have been utilized.Since the stickers were not on usage sheet, on (b)(6), when we asked the sales associate that covered the surgery, how he determined the lot numbers stated on the surgery sheet, his reply was "i read them off the box after they were opened".I have an e-mail back to this rep asking if the expired box was utilized or just opened.I will update this per when i receive his reply.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: device history review indicated all devices accepted into final stock met specification.Device evaluation could not be performed as tube set was not returned.Complaint history review indicated there have been no other similar complaints for this reported lot.Conclusion: a plausible root cause of the reported event is user error.
Event or Problem Description
It was reported that; we are unsure but it is possible that an expired box of tubing was utilized.The surgery date was (b)(6) 2017 and the expiration date on the tubing was 3/31/2017.This item was not in inventory in oracle to reserve as we only ever received 3 boxes per oracle and those 3 boxes were previously billed.We are not sure how/when we got this item however not.It was not transacted in oracle to us and therefore was not on our expiration report.Since the item wasn't in oracle to transact and since the sales representative had 4 kits, one of which being a loaner, we waited for the kit to be counted upon return to see if another lot number was missing from that kit (and would be transferred into our inventory to bill) however loaners did not show any of the item missing from their loaner kit.Additionally we asked the main sales rep at the account to do an inventory count to see what lot numbers were in the other kits in his possession to see if another lot number was missing and may have been utilized.Since the stickers were not on usage sheet, on (b)(6) when we asked the sales associate that covered the surgery, how he determined the lot numbers stated on the surgery sheet, his reply was "i read them off the box after they were opened".I have an e-mail back to this rep asking if the expired box was utilized or just opened.I will update this per when i receive his reply.

• Brand Name: ACCULIF TL TUBING SET
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6586502
• Report Number: 3004024955-2017-00021
• Device Sequence Number: 978845
• Product Code: MAX
• UDI-Device Identifier: 07613327067064
• UDI-Public: (01)07613327067064(11)150423(17)170331(10)03231519
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143616
• 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): 07/24/2017

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 Expiration Date: 03/31/2017
• Device Model Number: 905103
• Device Catalogue Number: 905103
• Device Lot Number: 03231519
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR