MAUDE Adverse Event Report: ZIMMER GMBH SCREWDRIVER HANDLE, CANNULATED, HEX-LOCK; N/A

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 11/17/2017

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.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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

(b)(6) reported: it was reported that on (b)(6) 2017 the screwdriver blade, cannulated, k- wire fixation screw, hex-lock, tx6 was defective after two uses.Also the following was reported: -no surgery delay, -no contributing condition related to event, -surgical technique was followed.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.

Manufacturer Narrative

Additional information has been received.It was now identified that this case is a duplicate of the existing case (b)(4) (mfr 0009613350-2017-00997).This incident has been reported on july 4, 2017 from our regional manager and the case (b)(4) (mfr 0009613350-2017-00997) has been created.Later on, the hospital informed the competent authorities about the same incident and zimmer biomet received the corresponding user report on november 17, 2017, from which the case (b)(4) (mfr 0009613350-2017-01739) has been created.Since the product reference reported in the user report (ref# : 503004425, screwdriver blade, mentioned in the initial medwatch report) was different than the one reported in the already existing case (ref#: 503004106, screwdriver handle), the double entry has not been primary identified.During investigation of the present case (b)(4), it was found that the event description does not match the complained product number.The event describes an issue with the screwdriver handle, however, the reported part number is the screwdriver blade.Clarification was requested and it was found out that only one incident occurred at the hospital and that the case (b)(4) is a duplicate of the case (b)(4).Please invalidate this case from your system as it is a duplicate from (b)(4) zimmer (b)(4) will invalidate this case from the system.(b)(4).

Event Description

It was now identified that this case is a duplicate of the existing case (b)(4) (mfr 0009613350-2017-00997).This present case (b)(4) will be invalidated.

• Brand Name: SCREWDRIVER HANDLE, CANNULATED, HEX-LOCK
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7120318
• MDR Text Key: 94933306
• Report Number: 0009613350-2017-01739
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• 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: 503004106
• Device Lot Number: 269A12
• Other Device ID Number: 00889024111950
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1