MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, FULLY THREADED ASNIS III Ø5.0X40MM; SCREW, FIXATION, BONE

Catalog Number	601740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that the patient was walking with a limp, has pain, swelling in ankle and in unable to walk.The patient told the doctor and was provided support hose and those didn't make a difference.Patient requires a wheelchair at times to move around.
Event or Problem Description
It was reported that the patient was walking with a limp, has pain, swelling in ankle and in unable to walk.The patient told the doctor and was provided support hose and those didn't make a difference.Patient requires a wheelchair at times to move around.
Additional Manufacturer Narrative
Correction - d4 lot# the reported event could not be confirmed based on the available information, since the device was not returned for evaluation and no other evidences, like pre-, intra- and post-operative x-rays, were provided no further evaluation is possible.A review of the device history was not possible because the communicated lot number was not valid.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the correct lot number was not communicated.¿ product field action (pfa) data was reviewed for the provided catalog.No pfa or recall were noted for the reported catalog number.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CANNULATED SCREW, FULLY THREADED ASNIS III Ø5.0X40MM
• 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: 18721291
• Report Number: 0008031020-2024-00105
• Device Sequence Number: 17726451
• Product Code: HWC
• UDI-Device Identifier: 07613327134827
• UDI-Public: 07613327134827
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K213199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 601740
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 122 KG