MAUDE Adverse Event Report: ZIMMER GMBH RASP ADAPTER W LENGTH MARK; N/A

Model Number N/A

Device Problems Complete Blockage (1094); Fracture (1260)

Patient Problems Debris, Bone Shedding (1803); Blood Loss (2597)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is available.Notes: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.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.(b)(4).

Event Description

It was reported that during the implantation of a revitan shaft there was a deadlock of the revitan rasp.Due to the attempt of forced striking back the rasp there was a breakage of the impactor causing a significant delay of about 120 minutes, femoral osteotomies with multiple cerclages and increased blood loss.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend has been identified.Event description: it was reported that during revision surgery on (b)(6) 2019 the revitan rasp size 16 got jammed.Subsequently the rasp adapter with length marking fractured during the attempt to remove the rasp.This led to a surgical delay of 120min, increased blood loss and a femoral osteotomy was required.The estimated usage of the instrument is 50 times.Review of received data: no medical data has been received.Device analysis: visual examination: the rasp adapter has been received for investigation.It can be confirmed that the instrument has fractured.Neither the crossbar nor the broken of hitting plate have not been received.The locking mechanism including slider with well legible length marking is inconspicuous and works as intended.On the distal half of the device countless indentations from hammer blows can be seen, especially on the side with the laser marking.The proximal bore hole has a several indentations on its rim, otherwise, nothing conspicuous to report.The distal bore hole has fractured in the area where the wall thickness is the least.Moreover, there are several indentations on the rim of this distal bore hole, also next to the fracture surface.Based on this visual examination the reported event can be confirmed.Review of product documentation: this device is intended for treatment.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Raw material certificate reviewed on: 21-jan-2020.The review did not identify any non-conformance.Inspection plan : characteristic no.08 feature, general requirements with scope of testing: 100%.Means.Of inspection: visual characteristic no.20 feature hardening and tempering of material with scope of testing: 100%.Means of inspection: visual characteristic no.61&62 feature bore hole (12.2 +0.15/0) with scope of testing: aql2.5.Means of inspection: caliper.Conclusion: it was reported that during revision surgery on (b)(6) 2019 the revitan rasp size 16 got jammed.Subsequently the rasp adapter with length marking fractured during the attempt to remove the rasp.This led to a surgical delay of 120min, increased blood loss and a femoral osteotomy was required.The estimated usage of the instrument is 50 times.The visual examination confirmed the reported event.The distal bore hole has fractured along the smallest material thickness.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).Several indentations from hammer blows have been caused in the area of the bore holes.It remains unknown, whether these indentations occurred during the attempt to remove the rasp or already previous to this event.Most likely the fracture has originated from such a surface deterioration when excessively high forces have been applied during the attempt to remove the jammed rasp.Based on the investigation, the most likely root cause for the reported event is the application of excessively high forces in combination with surface deterioration caused during use.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: RASP ADAPTER W LENGTH MARK
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9150995
• MDR Text Key: 167622315
• Report Number: 0009613350-2019-00585
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00409.501
• Device Lot Number: 4501714420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 91