MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX FULL THREAD 3.5MM / L24MM; PLATE, FIXATION, BONE

Catalog Number 614624S

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 03/13/2017

Event Type  Injury  

Manufacturer Narrative

The reported event that the distal screws pulled through the «distal posterior lateral humerus plate variax for right humerus 12 hole / l19», after the patient fell, could not be confirmed, since the devices were not returned for evaluation and no other evidences were provided.The involved plate and screws were not returned and an inspection could not be performed.Also, no x-rays were provided, and no further information regarding the patient and his immobilization were communicated.It was reported that ¿the patient had a plating, which was revised once, then it was revised for a second time and then some time post-operatively, the patient fell again and it was discovered that the distal screws had pulled through the plate¿.An incorrect post-operative care, can definitely lead to complications such as loosening or breakage of the implant.As per ifu (v15013): ¿these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation.¿ as per ifu (v15013), ¿the patient should be well informed that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.[¿] the risk of post-operative complication (e.G.Failure of an implant) is higher if patients are obese and/or cannot follow the recommendations of the physician because of any mental or neuromuscular disorder.For this reason those patients must have additional post-operative follow-up.¿ based on the investigation the case could be classified as patient-related.However, please note that more detailed information about the complaint event as well as the affected devices must be available in order to determine the exact root cause of the complaint event.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 report will be updated.

Event Description

The sales rep was informed that a patient was undergoing distal humeral plating when it was noted that the plate pulled loose and the screws were still in the bone.It has been confirmed that this event did not occur during the second revision, but after it.The patient had a plating, it was revised once (b)(4), it was revised a second time (b)(4) and then some time post-operatively, the patient fell again.It was discovered that the distal screws had pulled through the plate.The proximal screws remained in the correct position.The rep confirmed that during the surgery there had been no issue with hard bone reported and that the surgery was completed as expected.It was further confirmed that the correct device has been selected to drive the screws through the plate and they had been inserted at an angle of 15 degrees as per standard protocol.It was decided that the patient would not have further surgery to replace the screws and would have external support (pop or collar and cuff) whilst the bone healed.

• Brand Name: LOCKING SCREW VARIAX FULL THREAD 3.5MM / L24MM
• 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: 6491175
• MDR Text Key: 72751606
• Report Number: 0008031020-2017-00233
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540596901
• UDI-Public: (01)04546540596901(17)210831(10)V35859
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 614624S
• Device Lot Number: V35859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2016
• 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): Required Intervention