MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE HIP STEM, TRIAL RASP, B/7

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomets reference number of this file is (b)(4).
Event or Problem Description
During the surgery, when rasping, the guide pin fractured.Surgery delay of 15 min noted.Broken pieces were removed from the patient body.
Event or Problem Description
No event update.Investigation results are now available.
Additional Manufacturer Narrative
Review of event description: it was reported that during a hip surgery on (b)(6) 2020, when rasping, the guide pin fractured.The doctor is suggesting a design change as it takes a lot of effort to remove a rasp that has fractured in the femur.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the fitmore rasp shows some normal signs of usage.The connection pin is fractured at the transition to the face surface.Macroscopically, nothing obvious that could have favored or triggered the fracture can be observed.Based on the low power microscope investigation of the fracture surface it seems that on approx.20% beach lines are visible indicative of a possible fatigue fracture and 80% forced fracture.Further, on the face surface around the fractured pin some polishing can be seen.The polishing seems to be an imprint or derived from the instrument that connects with the pin.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: review of the device history records showed that the rasp was manufactured in aug 2008 and identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that during a hip surgery on oct 12, 2020, when rasping, the guide pin fractured.The doctor is suggesting a design change as it takes a lot of effort to remove a rasp that has fractured in the femur.The visual investigation showed that the connection pin is fractured at the transition to the face surface.Macroscopically, nothing obvious that could have favored or triggered the fracture can be observed.The fracture surface showed approx.20% beach lines which are indicative of a possible fatigue fracture and 80% forced fracture.Further, the review of the manufacturing documents showed that the instrument was manufactured in august 2008.A possible root cause could be related to the age of the rasp and that the material might have weakened slightly due to repetitive use over a timeframe of 12 years (fatigue fracture).After the fatigue frature was initiated, it is possible that the forces that have been applied on the rasp and pin during application may then contributed to the final fracture (forced fracture).Based on the investigation the reported event can be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: FITMORE HIP STEM, TRIAL RASP, B/7
• Common Device Name: FITMORE HIP STEM, TRIAL RASP, B/7
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10745607
• Report Number: 0009613350-2020-00502
• Device Sequence Number: 1126907
• Product Code: HTR
• UDI-Device Identifier: 00889024281783
• UDI-Public: 00889024281783
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: N\A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: N/A
• Device Catalogue Number: 01.00559.207
• Device Lot Number: 08.2452828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization