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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH ANN, BLUNT TIP SCREW, 4X44MM ROD, FIXATION

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ZIMMER SWITZERLAND MANUFACTURER GMBH ANN, BLUNT TIP SCREW, 4X44MM ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem Insufficient Information (4580)
Event Date 04/20/2022
Event Type  Injury  
Event Description
It was reported that one of the proximal screws backed out from the proper position one week after initial implantation. The surgeon is keeping an eye on the patient's condition. No revision surgery planned so far. No harm reported. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
(b)(4). Concomitant medical devices: ann, proximal humerus, right, 7x160mm; item# 47249616007; lot# 3091683. Blunt tip screw, 4x42mm; item# 47248604240; lot# 3073795. Blunt tip screw, 4x42mm; item# 47248604240; lot# 3076740. Cortical bone screw, 4x30mm; item# 47248613040, lot# 3073753. Cortical bone screw, 4x32mm; item# 47248613240, lot# 3068973. Proximal humerus nail cap, 10. 5x2. 5mm; item# 47248801002; lot# 3068978. Report source¿ foreign ¿ (b)(6). No product return. Product remains implanted. Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00282, 0009613350-2022-00283, 0009613350-2022-00284. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
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Brand NameANN, BLUNT TIP SCREW, 4X44MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key14433098
MDR Text Key292031895
Report Number0009613350-2022-00286
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00889024505469
UDI-Public(01)00889024505469(17)260601(10)3076741
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K181827
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47248604440
Device Lot Number3076741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/18/2022 Patient Sequence Number: 1
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