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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/195MM-STERILE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/195MM-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.019.195S
Device Problem Device-Device Incompatibility (2919)
Patient Problems Bone Fracture(s) (1870); Not Applicable (3189)
Event Date 05/08/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is not expected to be returned for manufacturer review/ investigation. (b)(4). A review of the device history record. Part: 04. 019. 195s, lot: l590322, manufacturing site: (b)(4), release to warehouse date: 22 nov 2017, expiry date: 01 nov 2022. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. Investigation summary: product was not returned. 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: this pc is related to (b)(4) which reports about the radiolucent drive. This pc reports about the drill bit. It was reported that on (b)(6) 2020, the patient underwent open reduction internal fixation surgery with the nail and the drill bit in question. During the drill with the drill bit and the radiolucent drive, the surgeon could not drill at all. The surgeon hammered the drill bit to make a pilot hole and drilled to the opposite cortex. The surgeon could not remove the drill normally, and he removed the drill with a pliers. The surgeon tried to insert a depth gauge a few times, but he couldn't. The surgeon confirmed by image intensifier that the fracture occurred at the distal nail. The surgeon made an incision, and he used 3 wires to fix the fracture. The surgeon commented that it was possible that the fracture occurred when the surgeon hammered the drill. The surgery was completed successfully with 60 minutes delay. No further information is available. Concomitant device reported: unknown locking screws (part # unknown, lot # unknown, quantity unknown), unknown end cap (part # unknown, lot # unknown, quantity 1), unknown depth gauge (part # unknown, lot # unknown, quantity 1), unknown radiolucent drive (part # unknown, lot # unknown, quantity unknown). This complaint involves four (4) devices. This report is for one (1) 8. 5mm ti multiloc humeral nail left/ cann/ 195mm-sterile. This report is 2 of 4 for (b)(4).
 
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Brand Name8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/195MM-STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key10080135
MDR Text Key192378117
Report Number8030965-2020-03668
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.019.195S
Device Lot NumberL590322
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/21/2020 Patient Sequence Number: 1
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