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

Catalog Number I-H0854-HA53

Device Problems Break (1069); Fracture (1260); Unintended Collision (1429); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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.

• Brand Name: CUSTOM 53 MM ACETABULAR REAMER
• Type of Device: HIP 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 Key: 4638771
• MDR Text Key: 5573599
• Report Number: 0002249697-2015-00955
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• 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 Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: I-H0854-HA53
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2015
• 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 Sequence Number: 1
• Patient Outcome(s): Other