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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: DHS/DCS PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: DHS/DCS PLATE, FIXATION, BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent for dhs plating surgery. During the surgery, the wrench doesn¿t work with screw in screw rod. Also, the latter doesn¿t fit in the former. It was unknown if the surgery completed successfully. The patient outcome is unknown. Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity 1). This complaint involves one (1) device. This report is for (1) unk - screws: dhs/dcs. This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4). This report is for an unk - screws: dhs/dcs/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Reporter is a j&j representative. 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.
 
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Brand NameUNK - SCREWS: DHS/DCS
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13194055
MDR Text Key289270467
Report Number2939274-2022-00063
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/07/2022
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 Received02/28/2022
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: 01/07/2022 Patient Sequence Number: 1
Treatment
DHS/DCS-WRENCH W/OCTAGONAL COUPL F/ONE-S; UNK - SCREWS: TRAUMA
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