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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS PLIERS,SURGICAL

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS PLIERS,SURGICAL Back to Search Results
Model Number 388.50
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 on (b)(6) 2020 during a routine inspection of consignment instrument sets at the hospital, the following items were found to be in need of repair or replacements. The rod introduction pliers for side opening implants does not hold the collar implant and the prongs that hold it must be splayed. The socket wrench with straight handle 11mm width across flats does not hold the collar, the collar drops out and does not self-retain. There is no patient involvement. Concomitant device: unk - mono/polyaxial screw collars/sleeves/heads (part# unknown, lot# unknown, quantity# unknown). This report is for 1 rod introduction pliers for side-opening implants. This is report 1 of 1 for (b)(4).

 
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Brand NameROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS
Type of DevicePLIERS,SURGICAL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
SZ 78532
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10088165
MDR Text Key192061001
Report Number2939274-2020-02504
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/26/2020
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number388.50
Device Catalogue Number388.50
Device LOT NumberT163174
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/21/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/14/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/26/2020 Patient Sequence Number: 1
Treatment
UNK - MONO/POLYAXIAL SCREW COLLARS/SLEEVES/HEADS
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