MAUDE Adverse Event Report: ZIMMER GMBH MIS, RASP HANDLE, DOUBLE OFFSET, RIGHT

Model Number N/A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer received the device for investigation on (b)(6) 2016.The investigation is pending.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).Investigation is pending.

Event Description

It was reported, that a mis, rasp handle, double offset, right was used in a surgery on (b)(6) 2016.It was also reported: "during surgery, the device fell apart.".

Manufacturer Narrative

It was reported that a mis rasp handle double offset right fell apart during surgery on (b)(6) 2016.No trend identified.The compatibility check was not performed as only one product was reported.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.No medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: visual inspection of the mis double offset rasp handle, right showed that the locking lever was detached from the rasp handle.There were signs of usage visible, especially a lot of dents at the strike plate.The spring was not broken, but there were signs of wear at the surface between the locking lever and the rasp handle.The mis double offset rasp handle right was assembled together and functional tests were conducted.The functional tests were performed using two different rasps: mis cls rasp size 9 and mis cls rasp size 15.Both rasps could be connected to and disconnected from the handle without any problems.Afterwards, the rasp was fixed and multiple hammer blows in both directions were performed on the striking plate of the rasp handle.The hammer blows caused a dislocation of the locking lever, but it didn't fell apart.However, even though the described failure could not be reproduced completely, the wear indicated that the spring had hit the housing during the hammer blows, creating slowly but steadily a chamfer like contour that might allow the spring to jump / slip off the housing.Functional tests also conducted within the investigation of earlier complaints showed that, if the lever is not assembled correctly (spring is out of its guidance) and the lever is unlocked and pushed down while forces are applied, it can become loose.Root cause determination using rmw: instrument breaks, deforms, diverges impairing its function due to inadequate design for intended performance => not possible, as based on complaint summary of the reported device an adverse trend due to design would have been detected.Instrument breaks, deforms, diverges impairing its function due to mechanical properties of material insufficient => not possible, as according to the material compatibility specification the material was tested.Fracture of instrument due to general corrosion (crevice, pitting, galvanic) => not possible, as no signs of corrosion could 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 that the surgeon was unfamiliar with the device and according to the per the surgical technique was followed.Instrument breaks or deforms due to off-label / abnormal-use => not possible, as no signs of off-label use could be detected.Instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition => possible, as the device disassembled during surgery it was not possible to use the handle with the rasp anymore.Instrument cannot be used with the connected instrument as intended due to failure of instrument assembly condition => possible, as the device disassembled during surgery, it was not possible to use the handle with the rasp anymore.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.The reported event could not be reproduced completely.However, it seems plausible, that the event happened due to the detected chamfer like contour of the housing, where the spring is in contact with the housing when in locked position.This chamfer like contour seems to be the result of repeated usage and might have facilitated the spring to jump out of the guidance.In combination with the forces applied during the surgery this might have initiated the loosing of the locking lever.However, an exact root cause could not be determined.The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: MIS, RASP HANDLE, DOUBLE OFFSET, RIGHT
• Type of Device: MIS, RASP HANDLE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5623331
• MDR Text Key: 44729840
• Report Number: 0009613350-2016-00623
• Device Sequence Number: 1
• Product Code: HTR
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00001.002
• Device Lot Number: 12.734963
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2012
• 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