MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Model Number 58803518

Device Problem Failure to Osseointegrate (1863)

Patient Problems Loss of Range of Motion (2032); Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 01/18/2023

Event Type  Injury  

Event Description

It was reported that the patient presented with pain in the right foot and in the implant.The patient had hardware removed due to mechanical failure/malfunction of fusion( right foot).The initial diagnosis was pseudarthrosis after fusion or arthrodesis.The pre-operative diagnosis was right hallux limitus with non-union.Non-union hallux interphalangeal joint fusion.The patient underwent revision right first metatarsal phalangeal joint fusion.Right foot hardware removal.Right hallux arthroplasty.Calcaneal bone graft harvesting.

Manufacturer Narrative

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

Manufacturer Narrative

Correction: d1, d2a, d2b, d4 (catalog#, lot#), gtin, g1, g4 (510(k)), h3, h6 (method code).The reported non-union can be confirmed based on the provided operation report of the revision surgery.The device inspection revealed the following: one (1) plate together with seven (7) screws was returned for evaluation.The plate is broken apart and does belong to the legacy stryker variax 2 foot system.Three (3) of the returned screws belong to the variax 2 system.The other four (4) screw belong most likely to the legacy wright medical cannulated screw system (css).The evaluation of these devices will be performed under the complaints 3216512, 3216513, 3223765 and 3223766.The visual inspection has shown that the returned 16mm variax locking screw is in a used condition, the head and as well the thread flanks have clearly visible wear marks.Also the locking thread is slightly worn, which indicates that the screw was locked in the plate as required.Afterwards it cannot be defined anymore if these damages occurred during implantation, in-situ or during extraction.Otherwise is the screw in a good condition and there is no indication that any issue at the screw did contribute to the reported non-union.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.No product related issue could be detected.There was no additional information about the event provided, it is unknown how long the implants were implanted, no x-rays and no information about the patient history/activity was provided.In addition, it is unknown how the returned implants from different systems are related to each other.Therefore the root cause of the reported non-union cannot be defined.During the investigation no indication could be detected that the returned screws did contribute to the reported non-union and there was no allegation against the screws, e.G.Loosening, reported.These findings speak against a screw related issue.If more information is provided, the case will be reassessed.

Event Description

It was reported that the patient presented with pain in the right foot and in the implant.The patient had hardware removed due to mechanical failure/malfunction of fusion( right foot).The initial diagnosis was pseudarthrosis after fusion or arthrodesis.The pre-operative diagnosis was right hallux limitus with non-union.Non-union hallux interphalangeal joint fusion.The patient underwent revision right first metatarsal phalangeal joint fusion.Right foot hardware removal.Right hallux arthroplasty.Calcaneal bone graft harvesting.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach TN 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg TN D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16362823
• MDR Text Key: 309390411
• Report Number: 3010667733-2023-00069
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327068689
• UDI-Public: 07613327068689
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 58803518
• Device Catalogue Number: 656316
• Device Lot Number: 1000476057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic