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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT REAMER

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT REAMER Back to Search Results
Catalog Number 352.040
Device Problem Device Issue
Event Date 01/27/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is an instrument and is not implanted/explanted. Date returned to manufacturer. Patient code (b)(4) used for: the complainant indicated that the drill bit broke intra-operative and a non-implant grade fragment is retained in the patient. Device history records review was conducted. The report indicates that the: dhr review: ip-00138211 5. 0mm flexible shaft part: 352. 040 lot: 2748586 manufacturing site: (b)(4). Release to warehouse date: 27. June 2011 no ncrs were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.

 
Event Description

It was reported that during a procedure for implanting a synthes lateral entry recon nail on (b)(6) 2018, a 4. 5mm/6. 5mm stepped drill bit large qc/485mm would not pass through the protection sleeves and the nail as it should. During this process, the drill bit broke inside of the patient bone. The broken fragment of the drill bit was retrieved and nothing was left in the patient. Also, a recon locking aiming arm for lateral entry femoral nails-ex was not working properly as it was misaligned with nail, but prior to insertion of femoral neck/head component, nail connection was checked and the aiming arm connection was secured as well. Two of the 11. 5mm/8. 5mm protection sleeve for recon locking and two 8. 5mm/3. 2mm wire guide for recon locking were also not guiding the drill bit properly through the nail. A standard insertion handle connected with the aiming arm wasn't working properly as the sales consultant heard some noise when the handle was being used. A cannulated connecting screw for standard insertion handle was not getting connected properly and a 5. 0mm flexible shaft was not able to pass over a 2. 5mm reaming rod. There was a surgical delay of 30 minutes and the surgeon was unable to implant recon screws into proximal femur. To complete the surgery, the surgeon opted to lock in dynamic hole by using a regular 4. 9mm locking volt. The surgery was completed and the patient was stable after the surgery. This complaint involves six (6) devices. This report is 6 of 6 for (b)(4).

 
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Brand Name5.0MM FLEXIBLE SHAFT
Type of DeviceREAMER
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ  2544
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7293462
Report Number2939274-2018-50760
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 01/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.040
Device LOT Number2748586
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/27/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-0656-2017

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