MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN ASNIS III CANNULATED 4.5 MM SELF-DRILL/TAP SCREW; SCREW, FIXATION, BONE

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The manufacturer became aware of a literature published by the ¿muskulo-skeletal radiology department, (b)(6) university, (b)(6).The title of this report is ¿trans-isthmic pars interarticularis screw fixation under ct and fluoroscopic guidance: technical success and clinical outcome in patients with symptomatic low-grade lumbar isthmic lysis', published on april 20, 2021, which is associated with the stryker ¿asnis iii cannulated screw¿ system.The article can be found at https://doi.Org/10.1007/s00330-021-07921-x.This report includes analysis of the clinical data that was collected on 50 patients, and the cases in this study range from 2012 and 2019.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that 2 patients experienced screw breakage.The report states, ¿ we report two cases of screw breakage in the cohort, discovered at the time of the phone interviews.¿ the report states, ¿in one of these cases, the patient presented a double-level isthmic lysis and a history of hemilaminectomy, which may have influenced the mobility around the screw and can maybe partly explain the screw breakage.However, none of the two reported cases was symptomatic and, in both cases, fortuitous discovery of hardware breakage was made during imaging test nonrelated to spine symptoms.In both cases, because the patients were not symptomatic, no specific management was undertaken, and no further fusion was performed.

• Brand Name: UNKNOWN ASNIS III CANNULATED 4.5 MM SELF-DRILL/TAP SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14108149
• MDR Text Key: 292727310
• Report Number: 0008031020-2022-00150
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• 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