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 01/13/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.As no lot number was provided, the device history records could not be reviewed.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 a depth gauge fractured during surgery.Attempts to obtain additional information have been made; however, no more is available.

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 description: a depth gauge has been received.It has been reported that the device broke during routine procedure and no parts fell into the patient.Review of received data: no medical data such as surgical notes or any other case-relevant documents received.Devices analysis visual examination: the depth gauge is broken, site of fracture at 50 mm mark.Additionally, the handle of the depth gauge is profoundly bent.The measuring part shows numerous scratches.And is also slightly bent.Based on this visual inspection the reported event can be confirmed.Measurements: to ensure the instrument has correct dimensions, relevant characteristic according to the inspection plan were measured with an angle meter and the caliper so 2083.Characteristic no.08 feature ¿angle 45°¿: measured value: 45°.Conclusion: the angle between handle and measuring area is correct.Characteristic no.16 feature ¿dimension 50mm +0.3mm/-0.3mm¿: specification: max.49.7mm; min.50.3mm, measured value: 49.86mm- conclusion: the length of the measuring part can be confirmed.Characteristic no.27 feature ¿diameter 2.5mm +0.1mm/-0.1mm¿: specification: max.2.6mm; min.2.4mm, measured value: 2.47m.Conclusion: the diameter next to the 50 mm mark can be confirmed.Review of product documentation inspection plan: characteristic no.08 feature ¿angle 45°¿ with scope of testing: fal.Means of inspection: inspection at supplier site.Characteristic no.16 feature ¿dimension 50mm +0.3mm/-0.3mm¿ with scope of testing: aql 2.5.Means of inspection: caliper.Characteristic no.27 feature ¿diameter 2.5mm +0.1mm/-0.1mm¿ with scope of testing: fal.Means of inspection: inspection at supplier site.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 the bent / out of shape handle of the instrument indicates the application of abnormally high bending forces.Damaged instruments, implants, body or wrong operational step due to surgeon or operating room (or) staff unfamiliar with instrument usage and handling: possible, as the bent / out of shape handle of the instrument indicates the application of abnormally high bending forces.Instrument breaks or deforms due to off-label / abnormal-use: possible, as the bent / out of shape handle of the instrument indicates the application of abnormally high bending forces.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 was forced by repeated, abnormally high bending forces.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed (b)(4).

• Brand Name: DEPTH GAUGE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7272477
• MDR Text Key: 100442757
• Report Number: 0009613350-2018-00245
• Device Sequence Number: 1
• Product Code: HTJ
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 75.80.15
• Device Lot Number: 10.575559
• Other Device ID Number: 00889024303270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1