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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

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SYNTHES GMBH 12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR Back to Search Results
Catalog Number 352.250S
Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
Event Type  Malfunction  
Manufacturer Narrative

Additional device product codes: hrx. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Initial reporter facility name: (b)(6) hospital. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the surgery for the non-union with the ria drive shaft and ria reamer head. This was a case of bone grafting to the ipsilateral distal tibia using ria for the femur. For a patient with 10. 5 mm diameter femur and medullary cavity, a 12 mm reamer head was opened. There was an attempt to insert the reamer head through the tube assembly, through the drive shaft 520 mm, and was initially difficult to insert. After retraction, the surgeon inserted the tube assembly by reaming through the reaming rod. The reamer head came off in the intrathecal space when shaving the isthmus, it was removed once and reattached. The same issue occurred; the reamer head came off at the same point. When reattaching the reamer head, it was confirmed that the hook part of the reamer head was damaged. Sufficient bone collection was completed, and the patient was transferred to bone transplantation. After surgery, it was found that the tip of the drive shaft was also damaged. The surgery was completed successfully without any surgical delay. The patient was reported as stable. Concomitant devices reported: ria tube assembly, for ria drive shaft (part number 314. 746, lot unknown, quantity 1). Ria driveshaft l520 (part number 314. 743, lot h427158, quantity 1). This report involves one (1) 12. 0mm reamer head-sterile for reamer/irrigator/aspirator. This is report 1 of 1 for (b)(4).

 
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Brand Name12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
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 Key11307245
MDR Text Key231150496
Report Number8030965-2021-00909
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/10/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.250S
Device LOT NumberH544000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/23/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/06/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/10/2021 Patient Sequence Number: 1
Treatment
RIA DRIVESHAFT L520.; RIA TUBEASSEMBLY MIN-L 520 F/314.743.
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