MAUDE Adverse Event Report: STRYKER GMBH ASNIS III CANNULATED TITANIUM SCREW, 8MM DIA, 25MM THREAD LENGTH; IMPLANT

Catalog Number UNK_SEL

Device Problems Break (1069); Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 01/01/2003

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

The manufacturer became aware of a study from department of orthopaedic surgery, pediatric center (b)(6).The title of the study is ¿complications at screw removal in slipped capital femoral epiphysis treated by cannulated titanium screws¿ which was published in 23-may-2006 and is associated with the asnis iii single cannulated titanium screw.Within that publication, intraoperative/ postoperative complications/ adverse events were reported, which occurred from 2003 to 2005.It was not possible to ascertain specific catalog number or patient information from the report, however, based on the review of the study devices have been identified as asnis iii single cannulated titanium screw with 8mm diameter and 25 mm thread length.A review of the complaint handling database revealed that the events have not been reported previously, therefore 18 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses difficulties in hardware retrieval because of screw head damage.3 out of 6 cases.Adverse consequences reported that pin (asnis iii screw) was extracted with the aid of jacob¿s chuck that may have led to prolonged surgery time.The study states, ¿the extraction forces needed were extremely high.[¿] 12 pins could be backed only 10¿15 mm before they got stuck.The head of the pin was cut off.[¿] in six cases the rest of the rest of the pin could be extracted with the aid of a jacob¿s chuck.[¿] the allen socket was worn out in all cases where the surgeon had difficulties to retrieve the hardware.[¿] difficulties in hardware retrieval were encountered in various insertion angles, pin lengths, and pin positions.They were seen on the slipped side as well as on the side pinned prophylactically.¿.

• Brand Name: ASNIS III CANNULATED TITANIUM SCREW, 8MM DIA, 25MM THREAD LENGTH
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8025449
• MDR Text Key: 125758597
• Report Number: 0008031020-2018-00931
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• 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): Other