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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5 REAMING ROD BALL TIP/950-STERILE REAMER

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5 REAMING ROD BALL TIP/950-STERILE REAMER Back to Search Results
Model Number 351.706S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Part # 351. 706s. Synthes lot # 82p3794. Supplier lot # 82p3794. Release to warehouse date: may 11, 2021. Expiration date: december 31, 2029. Manufactured by jabil inc. - monument. Nrwas generated for a hole near the urania seal of the pouch in 1/75 pieces. The packaging was reworked and product disposition was completed. This non-conformance is not relevant to the complaint condition since the complaint condition is stuck and not a packaging issue. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Visual inspection: the 2. 5 reaming rod ball tip/950-sterile (part #: 351. 706s, lot #: 82p3794) was received at us customer quality (cq). Visual inspection of the complaint device showed that the reaming rod was stuck in the jaws of the chuck. White and solidified foreign material which appear to be glue was observed on the rod next to the jaws of the chuck. The bolded tip was broken off and not returned. Functional test: a functional assessment was not performed with the complaint device due to the condition of the received device. However attempts to disassemble both devices was unsuccessful. Can the complaint be replicated with the returned device? unable to perform but the complaint could be confirmed. Dimensional inspection: specification, rod diameter, measured dimensions, rod diameter: conform, device used: hand micrometer. Document/specification review: current and manufactured revisions were reviewed. No design issues or discrepancies were identified. Complaint confirmed? yes. Investigation conclusion: this complaint is confirmed as the reaming rod was received stuck or jammed in the jaws of the chuck. Foreign material which is suspected to be a solidified glue was observed next to the jaws. It is believe the solidified glue may have solidified inside the chuck and causing the rod and the chuck to stick together. The bolded tip was broken off. No root cause could definitively be determined for the reported complaint condition. No new, unique or different patient harms were identified as a result of this evaluation. There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that on an unknown date, the patient underwent for a surgery. During the surgery, the reaming rod stuck in t-chuck and could not be removed. There was no surgical delay reported. The procedure was successfully completed. There was no patient consequence. This report involves one (1) 2. 5mm reaming rod with ball tip/950mm-sterile. This report is 2 of 2 for (b)(4).
 
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Brand Name2.5 REAMING ROD BALL TIP/950-STERILE
Type of DeviceREAMER
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12267588
MDR Text Key264957038
Report Number2939274-2021-04461
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10886982193858
UDI-Public10886982193858
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number351.706S
Device Catalogue Number351.706S
Device Lot Number82P3794
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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