MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X46MM TL15.5MM; SCREW, FIXATION, BONE

Model Number	325046S
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during removal of the screw, the material gradually progressively twisted and then disintegrated in the patient preventing the complete removal of the device.The doctor broke the screw as close to the bone as possible and it is distal enough not to interfere with a future total knee replacement.This resulted in a 30 minute surgical delay and there will be no need to schedule another surgery.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The recurring breakage of 4.0 mm asnis iii screws during implantation or explantation was covered by a nc opened and closed in 2013.No corrective action was deemed necessary.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 will be reassessed.H3: part of the screw remains in the patient, and the remainder was discarded.
Event or Problem Description
It was reported that during removal of the screw, the material gradually progressively twisted and then disintegrated in the patient preventing the complete removal of the device.The doctor broke the screw as close to the bone as possible and it is distal enough not to interfere with a future total knee replacement.This resulted in a 30 minute surgical delay and there will be no need to schedule another surgery.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X46MM TL15.5MM
• Common Device Name: 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: 17161252
• Report Number: 0008031020-2023-00239
• Device Sequence Number: 14866484
• Product Code: HWC
• UDI-Device Identifier: 07613327076196
• UDI-Public: 07613327076196
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K213199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 325046S
• Device Catalogue Number: 325046S
• Device Lot Number: C17069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Male