MAUDE Adverse Event Report: STRYKER GMBH VOLAR DR PLATE STANDARD RIGHT EXTRASHORT; PLATE, FIXATION, BONE

Catalog Number 54-25783S

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Event Description

During inbound processing, it was noticed that the sealing is damaged, there are fibers under it.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

The reported event could be confirmed, since the package is damaged as complained.The complained package was returned for evaluation.The visual inspection has shown that the shrink foil is damaged at the backside of the package.Otherwise is the package in a good condition with no visible damages.The closer inspection of the damage shows that at the start of the damage a scratch is in the box, there are two long fibers visible in this area and the material of the shrink foil is compressed above the damage.The damage looks the package was pushed over a long fiber carpet, damaging the foil and pushing some fibers into it.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.The kind of the damage indicates that the foil did get damaged at some point after the manufacturing process by inappropriate handling.In retrospective it is based on the provided information not possible to determine where or when in the supply chain the package did get damaged and therefore the root cause of this event cannot be defined.If more information is provided, the case will be reassessed.

Event Description

During inbound processing, it was noticed that the sealing is damaged, there are fibers under it.

• Brand Name: VOLAR DR PLATE STANDARD RIGHT EXTRASHORT
• Type of Device: 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: 18221853
• MDR Text Key: 329167837
• Report Number: 0008031020-2023-00413
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K133974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 54-25783S
• Device Lot Number: 1000523056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1