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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 1/8" HEADLESS PIN INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH 1/8" HEADLESS PIN INSTRUMENT Back to Search Results
Catalog Number 7650-1038
Device Problems Break (1069); Off-Label Use (1494); Use of Device Problem (1670)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 04/22/2015
Event Type  Malfunction  
Event Description

During t2 scn surgery, the screw of freehand target device broke when surgeon was hitting a pin with a hummer to insert the pin to bone. After that the pin did not be removed from the device.

 
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Manufacturer Narrative

The reported event indicates the subject 1/8" pin was used in conjunction with a trauma implant targetting device. This targetting device is designed for use with 4. 0mm and 2. 9mm steinmann pins (4. 0mm cat. # 11302110; 2. 9 mm cat. # 11302110) steinmann pins. Based on the provided information it has been determined that this event is associated with an off-label application. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

During t2 scn surgery, the screw of freehand target device broke when surgeon was hitting a pin with a hummer to insert the pin to bone. After that the pin did not be removed from the device.

 
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Brand Name1/8" HEADLESS PIN
Type of DeviceINSTRUMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4781311
MDR Text Key5859515
Report Number0002249697-2015-01624
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/22/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number7650-1038
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/13/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2015
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/19/2015 Patient Sequence Number: 1
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