MAUDE Adverse Event Report: ZIMMER GMBH SCREW FOR 75.11.00-05; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a surgery the flexible shaft of an instrument to engage the tip was unusable because the screw that should lock it unscrews and loses.The surgery has been completed with delay (15-30 minutes), time used to find another screwing system.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

Attempts to obtain additional information have been made; however, no more is available.No trend considering the following event is identified: screw loose.Device history records (dhr): the dhr check could not be performed as the lot number was not available.Event summary: it was reported that a flexible shaft could not be used during surgery because the screw would not lock it as it is loose.The surgery was successfully completed with another screwing system with a delay of 15-30 minutes.Review of received data: no medical data such as surgical notes or any other case-relevant documents received.Devices analysis: it was requested by zimmer biomet to return the product for an in-depth analysis, but it was not returned by the hospital.Root cause analysis root cause determination using rmw: instrument, breaks, deforms, diverge, or parts remain in wound.Due to inadequate design for intended performance not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Instrument, breaks, deforms, diverge, or parts remain in wound.Due to mechanical properties of material insufficient not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Instrument cannot be used with the mating instrument or mating implant as intended due to failure of instrument mating condition => possible, as a deterioration in function as a result of repeated use cannot be excluded.The manufacturing date of the instruments is unknown.Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling => possible, as a deterioration in function as a result of repeated use cannot be excluded.The manufacturing date of the instruments is unknown.Additionally, the screw is not supposed to be unscrewed from the flexible shaft.Damaged instruments, implants, body or wrong operational step due to surgeon or or staff unfamiliar with instrument usage and handling => possible, as it cannot be excluded based on the availabel information.The screw is not supposed to be unscrewed from the flexible shaft.Conclusion summary neither the products nor the lot numbers were available for the investigation.Therefore the event could not be recreated and it is unclear how the screw could "unlock".However, it has also been mentioned in this complaint that the screw would get lost during the cleaning process.It needs to be considered that the locking screw should not be unscrewed completely from the instrument for cleaning and disinfection.This would only be possible by turning the screw clockwise.In order to have an appropriate cleaning and disinfection of the whole instrument it is sufficient to loosen the screw (counter-clockwise) but it should always remain within the flex shaft (see pictures "unscrewed screw for cleaning" attached, which have been taken from an instrument of the same ref).However, as the instruments have not been returned for an investigation, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: SCREW FOR 75.11.00-05
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6933694
• MDR Text Key: 89996616
• Report Number: 0009613350-2017-01407
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PNA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• 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: 75.11.01-05
• Device Lot Number: UNKNOWN
• Other Device ID Number: 00889024302754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1