MAUDE Adverse Event Report: ZIMMER GMBH AVENIR, RASP WITH TRUNNION CONNECTION, 7

Model Number N/A

Device Problem Retraction Problem (1536)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 06/30/2016

Event Type  Injury  

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.Zimmer¿s reference number of this file is (b)(4).Investigation is ongoing.

Event Description

It was reported, that a avenir, rasp with trunnion connection, 7 was used in a surgery on (b)(6) 2016.It was also reported: "the rasp has repeatedly undetached itself during knocking with the rasp handle and got stuck in the medullary canal.Only after several attempts, could the rasp be removed." the surgery was delayed for 30 minutes.

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: an avenir, rasp with trunnion connection, 7 (ref: 01.06620.007 lot:14.969765) has been received.It is reported that the rasp repeatedly detached itself from the rasp handle during extraction from the cavity.The rasp got stuck in the medullary canal and several attempts were needed to remove it from the bone.A surgery delay of 30 minutes is reported.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis visual examination: the rasp is in good shape.A mark, most likely caused by the contact with the rasp handles, can be seen in the connection area.Beside this normal sign of usage, no further imperfections or deteriorations are visible.The handle was not reported/ returned so a visual examination is not possible.No measurement will be conducted as the connection area of the rasp has been 100% inspected for functionality during final inspection of the device (see point "inspection planning" below.The dhr of the affected lot indicates that the components met all specifications.The rasp's connection quality was examined by connecting the rasp to two different rasp handles.The rasp was fixated and hammer blows were applied to simulate the extraction of the rasp from the bone.The hold was excellent and with locked handles a disconnection of rasp and handle could not be reproduced.Review of product documentation compatibility: no compatibility check can be performed as only one product has been reported.Inspection planning: for the rasp, inspection plan: characteristics of different dimensions and angles of the rasp's connection area are 100% inspected.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 and the dhr certify the suitability of the material.Instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition.Possible, as the reported event indicates the rasp detached itself from the rasp handle during use.However, based on a functional test this could not be confirmed.Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling.Possible, as the rasp handle has not been returned it remains possible a wrong or damaged handle was used causing the reported issue.It is also feasible that the rasp handle applied has not been properly attached to the rasp (e.G.Locking lever not closed or foreign particle in connection area).Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling.Possible, as the rasp handle has not been returned it remains possible a wrong or damaged handle was used causing the reported issue.It is also feasible that the rasp handle applied has not been properly attached to the rasp (e.G.Locking lever not closed or foreign particle in connection area).Conclusion summary: based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.It remains unclear why the rasp handle used during surgery disconnected from the reported rasp several times.As the involved handle has not been returned this cannot be further investigated.The functional test conducted proves the returned rasp's connection area functions as intended.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: AVENIR, RASP WITH TRUNNION CONNECTION, 7
• Type of Device: AVENIR, RASP
• 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: 5818863
• MDR Text Key: 50318128
• Report Number: 0009613350-2016-01081
• Device Sequence Number: 1
• Product Code: HWA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.06620.007
• Device Lot Number: 14.969765
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2014
• 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