MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR LATERAL PLATE VARIAX CLAVICLE 5 HOLE / RIGHT; PLATE, FIXATION, BONE

Catalog Number	628225S
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device currently remains implanted and will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
At (b)(6) 2018, the variax clavicle plate was implanted for the fracture of the shaft of clavicle.The proximal part was fixed with 3.5mm screw and the distal part was fixed with 2.7mm screw.On x-p in a week after the operation, all distal part screws were backed out.The patient had no symptoms such as pain.Whether revision surgery will be performed is undecided.
Additional Manufacturer Narrative
The reported event that superior lateral plate variax clavicle 5 hole / right was alleged of 'poor fixation' could not be confirmed but it is visible on the x-ray that all the screws on one side were backed out.Based on investigation, the root cause was attributed to be either user or patient related.The failure was caused by a possible inadequate screw selection or a patient incident, unfortunately no further details could be obtained despite multiple attempts.Note that all returned screws are 2.7mmm.Original statement from our medical expert: the six lateral screws seem to be real thin (visible on the x-ray), compared to the 3.5mm.I would even doubt, that they are 2.7mm.Six screws should not be loosened after a week.I would assume that wrong sized screws were used.Usually you would use 3.5 mm screws for the diaphyseal part of the bone, medial and lateral (or proximal and distal as said here), for the epiphyseal part you would use spongious threaded screws in size 2.7mm.All screws should be locked, if possible and the two nonlocking longholes should only be used for the reposition.I would recommend the use of a torque wrench.However, normally the screws are fixed to tight making explantation challenging¿ 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 or Problem Description
At (b)(6) 2018, the variax clavicle plate was implanted for the fracture of the shaft of clavicle.The proximal part was fixed with 3.5mm screw and the distal part was fixed with 2.7mm screw.On x-p in a week after the operation, all distal part screws were backed out.The patient had no symptoms such as pain.Whether revision surgery will be performed is undecided.

• Brand Name: SUPERIOR LATERAL PLATE VARIAX CLAVICLE 5 HOLE / RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7966815
• Report Number: 0008031020-2018-00804
• Device Sequence Number: 1773430
• Product Code: HRS
• UDI-Device Identifier: 04546540687128
• UDI-Public: 04546540687128
• Combination Product (Y/N): N
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 628225S
• Device Lot Number: Y30439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR