MAUDE Adverse Event Report: STRYKER GMBH SYMPHYSIS-PUBIS PLATE, RADIUS 75 HOLES 6 LENGTH 92.5MM FOR SCREWS 3.5/4.5MM; PLATE, FIXATION, BONE

Catalog Number 425796S

Device Problems Material Discolored (1170); Tear, Rip or Hole in Device Packaging (2385)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

This device is not cleared for sale in the us, however a similar device is cleared for sale in the us.Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Customer reported that the sterile packaging of the 2x products had a cut in the inner wrap.The customer noted that the product appeared to be slightly blue.Customer used alternative plate to complete the case.

Manufacturer Narrative

Correction: refer to d4 lot#, d9/h3 device availability.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.No additional information was provided even after multiple attempts.A review of the device history was not possible because the correct lot number was not communicated.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.H3 other text : device disposition is unknown.

Event Description

Customer reported that the sterile packaging of the 2x products had a cut in the inner wrap.The customer noted that the product appeared to be slightly blue.Customer used alternative plate to complete the case.

• Brand Name: SYMPHYSIS-PUBIS PLATE, RADIUS 75 HOLES 6 LENGTH 92.5MM FOR SCREWS 3.5/4.5MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10428661
• MDR Text Key: 203652077
• Report Number: 0008031020-2020-02183
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 425796S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1