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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY CONNECTING BOLT INSERTER ROD, FIXATION

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ZIMMER BIOMET, INC. CEPHALOMEDULLARY CONNECTING BOLT INSERTER ROD, FIXATION Back to Search Results
Model Number N/A
Device Problems Crack (1135); Fracture (1260); Device Disinfection Or Sterilization Issue (2909)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Additional concomitant medical products: 00249003280, cephalomedullary connecting bolt inserter, 62499514; 00249003572, captured screwdriver freehand, 62641212; 00249003280, cephalomedullary connecting bolt inserter, 636470910. (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 01128, 0001822565 - 2018 - 01127, 0001822565 - 2018 - 01130.
 
Event Description
It was reported that the handle of the inserter was cracked. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4). This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. Visual inspection of the returned screwdriver confirmed that the blue handle cracked. Also noted multiple scratches on the handle indicative of use. The device history records were reviewed for deviations and/or anomalies with no deviations/anomalies identified. Root cause was unable to be determined. 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.
 
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Brand NameCEPHALOMEDULLARY CONNECTING BOLT INSERTER
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7298707
MDR Text Key101164813
Report Number0001822565-2018-01129
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PK091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 08/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00249003280
Device Lot Number63647091
Other Device ID Number(01) 00889024063556
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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