MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X60MM TL20MM; SCREW, FIXATION, BONE

Model Number	325060S
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that the asnis iii cannulated screw unthreaded at tip and fragments had to be retained within bone.Update: customer reported that during a orif elbow procedure, using asnis iii cannulated screw partially threaded 60mm, once screw within bone xrays were taken to assess and found foreign body at tip of screw that looked to be threading from screw.Screw was removed and foreign material remained within the medullary cavity.After examination, it was found that the tip had unthreaded and broken off within the bone.Another screw of the same size wasn't available so a shorter screw had to be selected.
Event or Problem Description
The customer reported that the asnis iii cannulated screw unthreaded at tip and fragments had to be retained within bone update : customer reported that during a orif elbow procedure, using asnis iii cannulated screw partially threaded 60mm, once screw within bone xrays were taken to assess and found foreign body at tip of screw that looked to be threading from screw.Screw was removed and foreign material remained within the medullary cavity.After examination, it was found that the tip had unthreaded and broken off within the bone.Another screw of the same size wasn't available so a shorter screw had to be selected.
Additional Manufacturer Narrative
The reported event could be confirmed, since the screw is broken as complained.The device inspection revealed the following: the visual inspection has shown that a fragment of about 5mm length is broken off from the cannulated screw, no fragments were returned for evaluation.The hexagon recess is strongly damaged, which indicates that the screw was exposed to excessive forces during insertion.The microscopic inspection has shown that the thread was first peeled off before it finally broke off at the visible deformation.The fracture face has the typical view of ductile overload fracture where the material was first plastically deformed before it finally broke.The relevant dimensions were verified during the investigation and no deviation from the specification could be detected.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.Based on investigation, the root cause was attributed to a use related issue.The failure was caused by a mechanical overload, most likely by a metallic contact either with a deformed guide wire or another screw, during the screw insertion.If more information is provided, the case will be reassessed.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X60MM TL20MM
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12813447
• Report Number: 0008031020-2021-00464
• Device Sequence Number: 14883941
• Product Code: HWC
• UDI-Device Identifier: 07613327078039
• UDI-Public: 07613327078039
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K000080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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 Expiration Date: 08/31/2024
• Device Model Number: 325060S
• Device Catalogue Number: 325060S
• Device Lot Number: B94998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2019
• 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 Sex: Unknown