MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III 4.0X38MM TL13MM; SCREW, FIXATION, BONE

Model Number	604638S
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
The surgeon was notified that the consignment device he implanted was expired; the decision was made to remove the screw from the patient, as the patient was still intubated in the icu.Swabs were taken to check for infection; no infection was found on the screw or in the patient.
Event or Problem Description
The surgeon was notified that the consignment device he implanted was expired; the decision was made to remove the screw from the patient, as the patient was still intubated in the icu.Swabs were taken to check for infection; no infection was found on the screw or in the patient.
Additional Manufacturer Narrative
H3 results and conclusion codes have been corrected.The reported event could be confirmed.Indeed, the device expired on the (b)(6) 2021 while the surgery date was on the (b)(6) 2021.The medical opinion of a medical expert was requested to evaluate the risk of this event: "[.] if the sterile barrier is not damaged prior the use of orthopaedic devices after the expiry date, no noticeable harm would result.In many cases the bacterial load would be too small to cause an infection or a self-limiting local infection would result which would not require any specific therapeutic measures.However in very rare cases potential contamination of the surgical field could result from this event.If a significant infection did result from this event, in most cases this would be curable with medical and/or surgical intervention.Only in very rare cases a permanent harm ( e.G.Chronical osteitis) result from this event." as a reminder, it is the user's responsibility to check the expiration date of the products before use, as mentioned in the ifu.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.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III 4.0X38MM TL13MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11815824
• Report Number: 0008031020-2021-00220
• Device Sequence Number: 19620197
• Product Code: HWC
• UDI-Device Identifier: 04546540089748
• UDI-Public: 04546540089748
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K000080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: 604638S
• Device Catalogue Number: 604638S
• Device Lot Number: V03607
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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