MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN_SELZACH_PRODUCT; IMPLANT

Catalog Number UNK_SEL

Device Problems Bent (1059); Loose or Intermittent Connection (1371)

Patient Problems Swelling (2091); Injury (2348)

Event Date 07/01/2015

Event Type  Injury  

Event Description

The customer reported that the patient had experienced a serious clavicle injury.A lock down band and a stryker lateral clavicle plate was used to assist in healing the injury.It was reported that due to the position of the clavicle plate, the screws are getting loose and are moving, causing a subcutaneous swelling.Moreover, towards the ac joint, the clavicle bends a bit downwards.The customer alleges that these issues would not arise if the distal part of the lateral clavicle plate would be bent a bit downwards.

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Even though the device was not returned for inspection, the reported incident of getting loose screws (s-41 - poor fixation) could be confirmed thanks to the x-rays provided by the customer.Based on the currently available information, the root cause can be attributed to a user-related issue.Our clinical expert was involved in this investigation and reported the following in his clinical statement: "all x-rays show unstable lateral clavicle fractures involving the ac joint.In all three cases the lateral fragment with articulation to the ac joint is very small.Such small lateral fragments are a borderline indication for plate fixation in general, including the variax superior lateral clavicle plates because the bone quality is poor (even in younger sportive patients) and the loading on the screws very close to the ac joint is very high.For such ¿very lateral¿ fractures a variax hook plate would be a much better alternative solution.When a superior lateral clavicle plate is used for treatment of such fractures, the lateral locking screws should be inserted with divergent axes to prevent back out via form fit.In the available x-rays the axes of the backed out screws look nearly parallel to each other, but only one x-ray view is presented.Nevertheless, even with divergent placement of the lateral locking screws postoperative mobilization has to be done with great care.Such orif does not allow for early active rehabilitation in the first 6 weeks until significant callus formation is visible on the follow up x-rays.Furthermore, it has been reported that 'the customer alleges that these issues would not arise if the distal part of the lateral clavicula plate would be bend a bit downwards'.All variax plates are anatomically pre-shaped plates, which match to an ¿average anatomy¿.For adaption of the plate to the individual anatomy there are bending irons in the variax instrument tray, which allow for easy shaping of the plate to achieve optimal fit to the bone." a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications for any material, manufacturing or design related problems were not determined as the lot number was not communicated.If the device is returned for investigation or if further information is available, the investigation will be reassessed.

Event Description

The customer reported that the patient had experienced a serious clavicle injury.A lock down band and a stryker lateral clavicle plate was used to assist in healing the injury.It was reported that due to the position of the clavicle plate, the screws are getting loose and are moving, causing a subcutaneous swelling.Moreover, towards the ac joint, the clavicle bends a bit downwards.The customer alleges that these issues would not arise if the distal part of the lateral clavicle plate would be bent a bit downwards.

• Brand Name: UNKNOWN_SELZACH_PRODUCT
• Type of Device: IMPLANT
• 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: 4939942
• MDR Text Key: 6036089
• Report Number: 0008031020-2015-00327
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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