MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III 6.5X40MM TL20MM; SCREW, FIXATION, BONE

Model Number	325044S
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that: "the screw has broken off at the thread.Fragment of the screw in the patient.Need for a new surgical intervention.Replacement of the screw.".
Additional Manufacturer Narrative
D4 has been updated to correct catalog#/gtin the reported event could be confirmed, since the device was returned and is indeed broken.The visual inspection showed that the whole threaded portion of the implant is missing.The shaft of the screw is slightly deformed, proving that force was used on the device.Since the device is cannulated, the surface of the breakage cannot be analyzed thoroughly.However, the clear deformation of the metal indicates the use of force during the use of the implant.The root cause can therefore be attributed to be user related.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 any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reported that: "the screw has broken off at the thread.Fragment of the screw in the patient.Need for a new surgical intervention.Replacement of the screw.".

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III 6.5X40MM TL20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11756499
• Report Number: 0008031020-2021-00204
• Device Sequence Number: 4138691
• Product Code: HWC
• UDI-Device Identifier: 07613327076165
• UDI-Public: 07613327076165
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: 325044S
• Device Catalogue Number: 326040S
• Device Lot Number: B91701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention