MAUDE Adverse Event Report: ZIMMER GMBH WAGNER REAMER; NONE

Device Problems Difficult to Remove (1528); Fitting Problem (2183)

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

Event Date 07/09/2015

Event Type  Other  

Manufacturer Narrative

The manufacturer did not receive devices or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.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).

Event Description

It was reported that an unknown wagner reamer was used in a surgery on an unknown date: when doing the last 4 or 5 wagner cases, they are reaming appropriately.The trial seems to fit very snug and is difficult to get out.Then, once they go to the implant, the implant seems to just fall in like it is too small.This event is reported for the 5 mentioned unknown wagner reamer in.

Manufacturer Narrative

The product was not returned for investigation.Dhr review: the dhr check could not be performed as the lot number was not available.Trend analysis: no trend was identified.Compatibility check the compatibility check could not be performed as no product information was provided.Review of incoming information it was reported that during wagner implantation, after proper reaming , the trial seemed to fit very snug and was difficult to get out.Then, once they went to the implant, the implant seemed to just fell right in like it was too small.No other documents were provided for investigation.Neither photos, nor the device were received; therefore the condition of the component is unknown.Patient factors that may affect the performance of the components such as bone quality and relevant medical history are unknown.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Despite that, all possible causes are reported in dfmea which is available for every zimmer wagner reamer and is continuously monitored and updated.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.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: WAGNER REAMER
• Type of Device: NONE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 57426761
• MDR Report Key: 4991473
• MDR Text Key: 22864644
• Report Number: 9613350-2015-00958
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other