MAUDE Adverse Event Report: ZIMMER GMBH DEPTH GAUGE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested but is currently not available.It is reported that the device will be returned for investigation.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¿s reference number of this file is (b)(4).

Event Description

It was reported that during a surgery on (b)(6) 2017 a depth gauge broke while bending it to work it into the acetabulum component to measure for the screw length.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend considering the following event is identified: instrument fractured.Event summary: it was reported that during a surgery the depth gauge broke while bending it to work it into the acetabulum component to measure for the screw length.Review of received data: no medical data such as surgical notes or any other case-relevant documents were received.Devices analysis visual examination: the depth gauge has been returned for an investigation.The whole measuring part has broken off and is deformed.Additionally, there are some signs of usage visible.Root cause analysis root cause determination using rmw: - instrument breaks, deforms, diverges impairing its function due to inadequate design for intended performance -> not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.- instrument breaks, deforms, diverges impairing its function due to mechanical properties of material insufficient -> not possible, as according to material compatibility specification the material has been tested.Further a systematic issue with material properties would have been detected as part of the issue evaluation assessment.- fracture of instrument due to general corrosion (crevice, pitting, galvanic) -> not possible, as nothing indicates the presence of corrosion.- fracture of instrument due to general corrosion (crevice, pitting, galvanic) -> not possible, as nothing indicates the presence of corrosion.- damaged instruments, implants, body or wrong operational step due to surgeon or or staff unfamiliar with instrument usage and handling => possible, as abnormally high bending forces might have been applied on the instrument while bending it.- damaged instruments, implants, body or wrong operational step due to surgeon or or staff unfamiliar with instrument usage and handling => possible, as abnormally high bending forces might have been applied on the instrument while bending it.- instrument breaks or deforms due to off-label / abnormal-use => possible, as abnormally high bending forces might have been applied on the instrument while bending it.Conclusion summary based on the returned product and the given information the complaint could be confirmed.The visual examination clearly confirmed the fracture of the device.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.However, in case of incorrect handling of the device, it is possible that the instrument deforms and eventually breaks due to repeated, abnormally high bending forces.This depth gauge is a measuring device only.It is not designed to handle such forces.Therefore, based on the given information and the results of the investigation, the fracture of the device might have been caused by a too high bending forces.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: DEPTH GAUGE
• Type of Device: NA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7082728
• MDR Text Key: 95175555
• Report Number: 0009613350-2017-01701
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• 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: 75.80.15
• Device Lot Number: 11.654453
• Other Device ID Number: 00889024303270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 76 YR