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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 2.5MM REAMING ROD W/BALL TIP 650MM-STERILE REAMER

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SYNTHES MONUMENT 2.5MM REAMING ROD W/BALL TIP 650MM-STERILE REAMER Back to Search Results
Catalog Number 351.709S
Device Problem Unsealed Device Packaging
Event Date 08/26/2016
Event Type  Malfunction  
Manufacturer Narrative

This device was used for treatment, not diagnosis. (b)(4). Device is an instrument and is not implanted/explanted. (b)(6). The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Part #: 351. 709s, lot#: h080083 (sterile) - 2. 5mm reaming rod with ball tip/650mm-sterile. Quantity (b)(4). No ncrs were generated during production. 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. Sterility documentation was reviewed and determined to be conforming. Investigation summary shows, the devices were received with the clear mylar web of the sterile packaging delaminating (fused layers separated). The reaming rods were undamaged. An investigation by the supplier confirmed the issue and found a deviation with the pouch's material supplier. The investigation is confirmed and further investigation is being documented under ((b)(6)'s internal non-conformance system). The preliminary investigation by the pouch manufacturer and tier 2 material supplier, the issue is believed to affect a limited number of pouches which were manufactured using a specific raw material lot from tier 2 supplier (b)(6). A quality event occurred during the manufacture of this lot of raw material and this has been confirmed by (b)(6). (b)(6) has procedures in place to ensure culling of all affected material when a quality event occurs. However an escape is suspected of occurring during manufacture of this lot. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Device report from synthes (b)(4) reports an event as follows: it was reported that during a procedure, it was difficult to open the packaging for the reaming rod as it was torn and split. The reaming rod was unusable, the surgery was prolonged about 15 minutes with risk of cancellation if another reaming rod product is not available. This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

A product investigation was completed: the devices were received with the clear mylar web of the sterile packaging delaminating (fused layers separated). The reaming rods were undamaged. An investigation by the supplier confirmed the issue and found a deviation with the pouch's material supplier. The investigation is confirmed. Preliminary investigation by the pouch manufacturer and tier 2 material supplier, the issue is believed to affect a limited number of pouches which were manufactured using a specific raw material lot from tier 2 supplier (b)(4). A quality event occurred during the manufacture of this lot of raw material and this has been confirmed by (b)(4). (b)(4) has procedures in place to ensure culling of all affected material when a quality event occurs. This is a confirmed manufacturing issue, and steps have been taken to address it. 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.

 
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Brand Name2.5MM REAMING ROD W/BALL TIP 650MM-STERILE
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5999992
Report Number1719045-2016-10736
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/26/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number351.709S
Device LOT NumberH080083
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/02/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/15/2016
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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