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

Catalog Number	628205
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported by the pharmacist, that when modeling a variax clavicle plate using the instrumentation from the ancillary, the surgeon noticed a crack in the plate near the drilling hole.He used another plate and bend it without any issue.
Additional Manufacturer Narrative
The reported event that during remodeling of a ¿superior lateral plate variax clavicle 5 hole / left¿, using the instrumentation from the ancillary, the surgeon noticed a crack in the plate near the drilling hole, could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Since the actual ¿superior lateral plate variax clavicle 5 hole / left¿ was not returned, a visual inspection could not be performed.It was reported that the plate cracked near the drilling hole, but no other information regarding the actual contouring of the plate were communicated.As per ifu (v15013) ¿contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load.If contouring is necessary, allowed by design or prescribed by stryker, the physician should avoid sharp bends, reverse bends or bending the device at a screw hole.¿ a possible bending of the plate around a hole, could definitely lead to a cracked/broken plate.As per ifu (v15013) ¿ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments.¿ based on the investigation, the root cause would be attributed to a user related issue due to a mishandling of the device during contouring.However, please bear in mind that more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint.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 the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not received.
Event or Problem Description
It was report by the pharmacist, that when modeling a variax clavicle plate using the instrumentation from the ancillary, the surgeon noticed a crack in the plate near the drilling hole.He used another plate and bend it without any issue.

• Brand Name: SUPERIOR LATERAL PLATE VARIAX CLAVICLE 5 HOLE / LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6539070
• Report Number: 0008031020-2017-00277
• Device Sequence Number: 13669258
• Product Code: HRS
• UDI-Device Identifier: 07613252442288
• UDI-Public: (01)07613252442288(10)V49203
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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: Health Professional
• Device Catalogue Number: 628205
• Device Lot Number: V49203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 06/07/2017
• 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: Other