MAUDE Adverse Event Report: STRYKER GMBH U-BLADE INSERTER GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1320-0340
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "a part of u-blade inserter was broken off.".
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: "a part of u-blade inserter was broken off.".
Additional Manufacturer Narrative
Please note correction to d3 (manufacturer entity).The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received u-blade inserter shows signs of usage evident by the appearance of the surfaces and other marks.One of the two pins which exert pressure during insertion was found to be broken off completely.The fracture pattern shows signs of a forced brittle fracture evident by a relatively uniform & smooth surface.No signs of plastic deformation were observed.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 appearance of the breakage surface of the pin shows features of a forced brittle fracture hence the issue is deemed to be user related.However, the real root cause of the breakage as to how it happened could not be determined.Nevertheless, it can be ascertained that the root cause is not related to a deficiency of the device but is most likely related to mishandling of the device intra-operative procedure.Also as the device had been in use for a long time (manufactured in 2012) we can safely say that the device had fulfilled its tasks in former surgeries as intended without reporting any issues.If any further information is provided, the complaint report will be updated.

• Brand Name: U-BLADE INSERTER GAMMA3®
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16986342
• Report Number: 0009610622-2023-00171
• Device Sequence Number: 6693275
• Product Code: HSB
• UDI-Device Identifier: 04546540504296
• UDI-Public: 04546540504296
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032244
• 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): 07/12/2023

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 Model Number: 1320-0340
• Device Catalogue Number: 13200340
• Device Lot Number: K166162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2012
• 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