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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CUSTOM 53 MM ACETABULAR REAMER HIP INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH CUSTOM 53 MM ACETABULAR REAMER HIP INSTRUMENT Back to Search Results
Catalog Number I-H0854-HA53
Device Problems Fracture; Unintended Collision; Detachment of Device or device Component; Material Integrity Problem
Event Date 03/03/2015
Event Type  Malfunction  
Event Description

It was reported that surgeon was reaming the patient's acetabulum and when he went to remove the reamer the attachment part on the reamer broke off as it got caught on soft tissue.

 
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned due to hospital policy. Additional information has been requested and if received, will be provided in the supplemental report. Not returned to manufacturer.

 
Manufacturer Narrative

The returned device was shipped to the supplier, (b)(4), for evaluation. The supplier confirmed the event. The sample was inspected for the reported event and it was observed that the crossbars had broken and separated away from the reamer shell. Upon magnification, the reamer teeth were inspected and most of them were observed to be dull and worn. Worn reamers will exhibit decreased cutting efficiency over time and will require additional forces to ream correctly causing additional stress on the welded edges of the cross bars. These additional forces can cause the observed breakage. The failure mode is attributed to wear. Dull reamers occur as a result of the product exceeding its expected use. Manual surgical instruments have a limited life span which is generally determined by wear or damage due to repeated intended use. Ifu instructs customers and end users to visually inspect instrument for damage and wear and to discard instruments with dull cutting edges or damages. The lot number could not be confirmed. There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event. No further investigation is required.

 
Event Description

It was reported that surgeon was reaming the patient's acetabulum and when he went to remove the reamer the attachment part on the reamer broke off as it got caught on soft tissue.

 
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Brand NameCUSTOM 53 MM ACETABULAR REAMER
Type of DeviceHIP INSTRUMENT
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 Key4638771
Report Number0002249697-2015-00955
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberI-H0854-HA53
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/27/2015 Patient Sequence Number: 1
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