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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MEZZOVICO ROD, FIXATION, INTRAMEDULLARY

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SYNTHES MEZZOVICO ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Numbness (2415)
Event Type  Injury  
Manufacturer Narrative
Unknown when the nerve damage occurred, but was sometime between procedure on (b)(6) 2016 and a couple of days later when the patient experienced numbness ((b)(6) 2016). 510k: this report is for an unknown screw/unknown lot. Part and lot number are unknown; udi number is unknown. Part is either part 04. 005. 412s, lot 9795591 (4. 0mm ti locking screw w/t25 stardrive 22mm f/im nails-ster, udi: (b)(4) or part 04. 005. 410s, lot 9049130 (4. 0mm ti locking screw w/t25 stardrive 20mm f/im nails-ster, udi: (b)(4), but it is unknown device is the complained screw. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). A device history record review was completed for both potential part/lot combinations: manufacturing location: (b)(4). Part 04. 005. 412s, lot: 9795591: manufacturing date: january 15, 2016. Expiry date: january 01, 2026. Article was sterilized by supplier (b)(4) with lot number 9795591. Non sterile article 04. 005. 412 was manufactured with lot number 9786769. Part 04. 005. 410s, lot 9049130: manufacturing date: july 09, 2014. Expiry date: june 01, 2024. Article was sterilized by supplier (b)(4). Non sterile article 04. 005. 410 was manufactured with lot number 8975521. No deviation was found in the device history record review. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 europe reports an event in (b)(6) as follows: it was reported the patient had a multilock nail implanted for proximal humeral diaphyseal fracture procedure on (b)(6) 2016. Within a couple of days after the procedure, the patient claimed that she could not move her arm. The surgeon suspected the implanted screw might be causing the numbness. A revision procedure occurred on (b)(6) 2016. During that procedure, the surgeon confirmed the damage of the radial nerve where the most distal screw was implanted. He explanted the screw, sutured the damaged nerve and completed the procedure successfully. With the x-rays taken at the revision procedure, it was confirmed that the nail was inserted from the slight external-rotation position to the forward direction. The patient is reportedly doing well. This report is for an unknown screw. This is report 2 of 2 for (b)(4).
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES MEZZOVICO
zona industriale 4
mezzovico CH680 5
SZ CH6805
Manufacturer (Section G)
SYNTHES MEZZOVICO
zona industriale 4
mezzovico CH680 5
SZ CH6805
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6139071
MDR Text Key61246679
Report Number1000562954-2016-10220
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received11/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/01/2016 Patient Sequence Number: 1
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