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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD SCREW, FIXATION, BONE

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ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD SCREW, FIXATION, BONE Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available
Event Date 10/16/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: distal lateral fibular plate left 6 holes 106 mm length pn: 47235701806 ln: 63550687, 2. 7 mm locking screw 14 mm length pn: 47482801402 ln: 63671062, 2. 7 mm locking screw 16 mm length pn: 47482801602 ln: 63869781 , 2. 7 mm locking screw 12 mm length pn: 47482801202 ln: 63861780 , 2. 7mm locking screw 12mm long pn: unk ln: 62348896, 2. 7 mm locking screw 18 mm length pn: 47482801802 ln: 63861772, cortical bone screw self-tapping hex head 3. 5 mm diameter 18 mm length pn: 47234801835 ln: 63098016, cortical bone screw self-tapping hex head 3. 5 mm diameter 12 mm length pn: 47234801235 ln: 63406688, cortical bone screw self-tapping hex head 3. 5 mm diameter 40 mm length pn: 47234804035 ln: 61168845, cortical bone screw self-tapping hex head 3. 5 mm diameter 46 mm length pn: 47234804635 ln: 61214651. Report source: foreign - (b)(6). Following the removal of contamination on the devices, scanning electron microscopy identified isolated pitting corrosion at the screw plate interface constrained to the locking threads of the plate and the screws. The isolated pitting was not identified in other locations of the locking plates and screws, including the discolored areas surrounding the holes from which the tissue deposits were removed. Review of device history record did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event. The analysis confirms the device and it¿s materials are conforming to specifications. Root cause is unable to be determined at this time. The device labeling states that in-vivo implant corrosion is a possible adverse effect that may be anticipated as the device is implanted in a corrosive environment. Occurrence rates are within the expected rates therefore; no further action is needed at this time. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

It was reported that the patient underwent a revision due to apparent infection. It was further reported that a screw backed out.

 
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Brand NameCORTICAL BONE SCREW SELF-TAPPING HEX HEAD
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key9175775
Report Number0002648920-2019-00740
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number47234801235
Device LOT Number63406688
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/29/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/13/2016
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 10/10/2019 Patient Sequence Number: 1
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