MAUDE Adverse Event Report: STRYKER GMBH BARREL REAMER ASSEMBLY SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	704006-20
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "when opening the box (consignment product) during the surgery, the drill bit of the omega cephalic screw was missing.The operation took a long time with the consequent risk for the patient.As an alternative, material from another commercial company was sought.It had to be sterilized and implanted, all of this took some time but the surgery was completed.To date, no adverse effects have been reported in the patient.".
Event or Problem Description
As reported: "when opening the box (consignment product) during the surgery, the drill bit of the omega cephalic screw was missing.The operation took a long time with the consequent risk for the patient.As an alternative, material from another commercial company was sought.It had to be sterilized and implanted, all of this took some time but the surgery was completed.To date, no adverse effects have been reported in the patient.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation as it was missing, and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.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 lot number was not communicated.Based on investigation, the root cause was attributed to a distribution related issue.As the device was under stryker consignment when the event occurred, a local non-conformity was opened to cover this missing device event to avoid such an occurrence in the future.In addition, and in this relation, the instructions for use also indicate the user should ultimately ensure all components are available before the procedure begins: before every operation, ensure that all components and devices to be used during the operation are available in the operation theatre and function correctly with each other.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: BARREL REAMER ASSEMBLY SHORT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22105945
• Report Number: 0008031020-2025-00935
• Device Sequence Number: 20867933
• Product Code: LXH
• UDI-Device Identifier: 07613153054481
• UDI-Public: 07613153054481
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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 Catalogue Number: 704006-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown