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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: FNS PLATE, FIXATION ,BONE   

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SYNTHES GMBH UNK - PLATES: FNS PLATE, FIXATION ,BONE    Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2021
Event Type  Malfunction  
Manufacturer Narrative

Product complaint # (b)(4). This report is for an unk - plates: fns/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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 for a revision surgery due to pain. Originally, the patient underwent for a surgery with fns implants on (b)(6) 2021. On (b)(6) 2021, the patient was reported pain and scheduled for revision surgery. In the revision, after the anti-rotation screw was removed, when the surgeon tried to remove the locking screw with an extraction screwdriver, the screwdriver broke, and the fragment was remained in the screw head. The revision surgery was completed successfully within 30minutes delay. No further information is available. Concomitant device reported. Carbide drill bit ø4 f/instr (part# 309. 004s, lot# unknown, quantity# 1). Diamond bar (part# 309. 004s, lot# unknown, quantity# 1). Sparecenterpin f/309. 065 (part# 309. 670, lot# unknown, quantity# 1). Unk - nail head elements: fns bolt (part# unknown, lot# unknown, qty1). Unknown unk - nail head elements: fns antirotation (part# unknown, lot# unknown, qty1). This complaint involves (4) devices. This report is for (1) unk - plates: fns. This report is 2 of 4 for (b)(4). Related product complaint: (b)(4).

 
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Brand NameUNK - PLATES: FNS
Type of DevicePLATE, FIXATION ,BONE   
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12288939
MDR Text Key265460944
Report Number8030965-2021-06476
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial
Report Date 07/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received07/09/2021
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: 08/06/2021 Patient Sequence Number: 1
Treatment
CARBIDE DRILL BIT Ø4 F/INSTR STEEL+TI; CYLINDER F/INSERTION INSTR; DIAMOND BAR; MULTIFUNCTION ROD F/INSERTION INSTR; SPARECENTERPIN F/309.065; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - SCREWDRIVERS; UNK - SCREWS: FNS LOCKING
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