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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM / TI CANN FRN / PF 360MM / RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM / TI CANN FRN / PF 360MM / RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.033.936S
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Expiration date is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure. Also,the patient is reported to have unknown injuries due to the nail. There is no evidence of product malfunction. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. A review of the device history record has been requested. 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
It was reported that n (b)(6) 2018, the patient has sustained injuries from synthes products being defective. It was further reported that synthes devices were implanted in the patient on (b)(6) 2018. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand Name9MM / TI CANN FRN / PF 360MM / RIGHT - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8906144
MDR Text Key154739302
Report Number2939274-2019-59889
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.033.936S
Device Catalogue Number04.033.936S
Device Lot NumberL838623
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2018
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: 08/19/2019 Patient Sequence Number: 1
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