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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC UNK - PLATES: VA-LCP DISTAL RADIUS PLATE, FIXATION, BONE

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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC UNK - PLATES: VA-LCP DISTAL RADIUS PLATE, FIXATION, BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2021
Event Type  malfunction  
Manufacturer Narrative
This report is for an unk - plates: va-lcp distal radius /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. Based on the information available, it has been determined that no corrective and 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 surgery treating radius. In the surgery, the screw penetrated the screw hole. The distal part of the plate did not fit the bone, the surgeon ended up using another plate and finished the surgery. The surgery was completed within 30 minutes delay. The patient condition is stable. Concomitant device reported: unk insertion instruments: trauma (part# unknown; lot# unknown; quantity: 1). This complaint involves two (2) devices. This report is for (1) unk - plates: va-lcp distal radius. This report is 3 of 3 for (b)(4).
 
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Brand NameUNK - PLATES: VA-LCP DISTAL RADIUS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
1302 wright lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13012269
MDR Text Key288109636
Report Number8030965-2021-10248
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 Other,Foreign,Health Professional
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/15/2021 Patient Sequence Number: 1
Treatment
UNK - SCREWS: VA LOCKING; VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA
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