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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH DEPTH GAUGE

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ZIMMER GMBH DEPTH GAUGE Back to Search Results
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).
 
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Brand NameDEPTH GAUGE
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
MDR Report Key7272477
MDR Text Key100442757
Report Number0009613350-2018-00245
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
PMA/PMN Number
PN/A
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received02/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number75.80.15
Device Lot Number10.575559
Other Device ID Number00889024303270
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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