MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX FULL THREAD 3.5MM / L26MM; PLATE, FIXATION, BONE

Catalog Number 614826S

Device Problems Component Falling (1105); Unsealed Device Packaging (1444); Product Quality Problem (1506); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

When a user opened the box, the tyveks of both inner and outer packages were opened.The user could not use the implant, becasuse it was dropped when the pack was taken from the box.

Manufacturer Narrative

The reported event that bone screw variax full thread 3.5mm/l26mm was alleged of 'out from the holder/impactor/blister' could not be confirmed, since the tyvek blisters were not returned for evaluation and no other evidences were provided.The returned screw is conforming to specifications and fully functional.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate handling prior to an operation.Note that we had only received the screw in a plastic bag.Unfortunately the tyveks of both inner and outer packages had not been returned.The picture shows clearly though that someone opened both tyveks layers nicely (no damages visible).Package must have been opened during another surgery where the surgeon may have opted for another screw length instead.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

When a user opened the box, the tyveks of both inner and outer packages were opened.The user could not use the implant, becasuse it was dropped when the pack was taken from the box.

• Brand Name: BONE SCREW VARIAX FULL THREAD 3.5MM / L26MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6825575
• MDR Text Key: 83951522
• Report Number: 0008031020-2017-00496
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K101056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 614826S
• Device Lot Number: L09334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other