MAUDE Adverse Event Report: STRYKER GMBH 2.7MM XXL VOLAR DR PLATE, STAND., LEFT; PLATE, FIXATION, BONE

Model Number	54-25424
Medical Device Problem Codes	Off-Label Use (1494); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
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.
Event or Problem Description
As reported: "we had ordered on 05/07/2022, 2 variax palmar plates reference 54-254 25.5 and 54-254 24.5.On the other hand, you had sent the references 54-254 26 and 54-254 24: references which do not correspond to the order.We have not received any information from you on this "inconsistency": sending another reference without information, non-existent references from you.Indeed, we should have ordered references 54-254 26.S and 54-254 24.S because references 54-254 24.5 and 54-254 24.5 do not exist.Upon receipt, we did not observe this spontaneous modification on your part; consequently, the non-sterile plates received, initially requested by the hospital as sterile, followed the circuit of sterile implantable medical devices within our establishment.This resulted in the implantation of a non-sterile dm in a patient, as well as the removal of this plate during a second intervention.".Only 1 plate was implanted then explanted (54-25424).
Additional Manufacturer Narrative
Correction - please refer to d9/h3 - device was not returned for investigation.The reported event could be confirmed; since the event description and supporting evidence was provided which confirms the alleged failure mode.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user-related issue.The user intended to use sterile products, however, unawareness at their end led to incorrect order placement.The order received by customer service was for 'unsterile' devices, as confirmed by them, and the same was delivered.Still, it is the responsibility of the customer to check the expiry date and sterility prior to any surgical intervention.This is required as per ifu.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text: device disposition is unknown.
Event or Problem Description
As reported: "we had ordered on (b)(6) 2022, 2 variax palmar plates reference 54-254 25.5 and 54-254 24.5.On the other hand, you had sent the references 54-254 26 and 54-254 24: references which do not correspond to the order.We have not received any information from you on this "inconsistency" sending another reference without information, non-existent references from you.Indeed, we should have ordered references 54-254 26.S and 54-254 24.S because references 54-254 24.5 and 54-254 24.5 do not exist.Upon receipt, we did not observe this spontaneous modification on your part; consequently, the non-sterile plates received, initially requested by the hospital as sterile, followed the circuit of sterile implantable medical devices within our establishment.This resulted in the implantation of a non-sterile dm in a patient, as well as the removal of this plate during a second intervention." only 1 plate was implanted then explanted (b)(4).

• Brand Name: 2.7MM XXL VOLAR DR PLATE, STAND., LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15947200
• Report Number: 0008031020-2022-00669
• Device Sequence Number: 15104328
• Product Code: HRS
• UDI-Device Identifier: 07613252042495
• UDI-Public: 07613252042495
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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: Health Professional
• Device Model Number: 54-25424
• Device Catalogue Number: 54-25424
• Device Lot Number: 1000483784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female