MAUDE Adverse Event Report: ZIMMER GMBH FITMORE TRIAL RASP B SIZE 9

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported, that a fitmore trial rasp b size 9 was used in a surgery on (b)(6) 2016.The rasp broke during surgery.The surgery was completed with another rasp.

Manufacturer Narrative

Device history records (dhr) review results: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend identified.Event summary: the rasp broke during surgery.The surgery has been completed with another rasp.Extended surgery, time 0-15 min.Review of received data: 2 photographs showing the broken pin have been received.Devices analysis: visual examination: connecting-pin of the rasp is broken.Measurements: to ensure the connection pin has correct dimensions, the relevant characteristic.According to the inspection plan were measured.The pin is within the tolerance.Further the dhr indicates that the released components met all requirements to perform as intended.Review of product documentation: no compatibility check can be performed as only one product has been reported.Inspection plan: characteristic feature ¿aussen" with scope of testing: 100 %.Characteristic feature ¿funktionsprüfung" with scope of testing: 100 %.Root cause analysis: instrument, breaks, deforms, diverge, or parts remain in wound due to inadequate design for intended performance.Not possible as according to the complaint summary an adverse trend due to inadequate design would have been detected.Instrument, breaks, deforms, diverge, or parts remain in wound due to mechanical properties of material insufficient.Not possible as the material compatibility specification confirms the suitability of the material.Fracture of instrument due to general corrosion (crevice, pitting, galvanic).Not possible as no signs of corrosion can be detected.Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling.Not possible as nothing indicates the surgeons or staff was unfamiliar with the instrument usage and handling.Instrument breaks or deforms due to off-label / abnormal-use.Possible as the rasp could have been treated with abnormally high forces.Instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition.Possible as the connection pin is broken the rasp cannot be connected to the rasp handle any longer.Conclusion summary: based on the returned product and the given information the complaint could be confirmed, however an exact root cause could not be determined.Most likely extraordinary high forces acting during surgery or an off-label use caused the reported event.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: FITMORE TRIAL RASP B SIZE 9
• Type of Device: FITMORE TRIAL RASP
• Manufacturer (Section D): ZIMMER GMBH; sulzer-allee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5488451
• MDR Text Key: 39933754
• Report Number: 9613350-2016-00264
• Device Sequence Number: 1
• Product Code: HTR
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 01.00559.209
• Device Lot Number: 09.2489407
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other