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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ENDPIECE WITH DOUBLE JOINT; TRACTION, APPARATUS, NON-POWERED
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ENDPIECE WITH DOUBLE JOINT; TRACTION, APPARATUS, NON-POWERED Back to Search Results
Model Number 394.44
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
It was reported that on an unknown date, the patient underwent for a procedure.During the procedure, following equipment¿s was broken.It was unknown if the procedure completed successfully.The patient impact was unknown.(1)radiolucent insertion (3) holdsleeve w/wingscr l105 i- 6 f/large- (2)doublejoint cpl f/large- distract (2)holdsleeve w/wingscr l55 i- 6 f/large-d (3)red forceps points one bent tip/174 (1)red forceps serrated jaw-ratchet 144 (1)reduction forceps points ratchet 200.This complaint involves thirteen (13) devices.This report is for (1) endpiece with double joint.This report is 9 of 12 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Reporter is a j&j representative.The device was received, the investigation is in progress, 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.
 
Manufacturer Narrative
Product complaint # pc-(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Service and repair evaluation: the customer reported the doublejoint cpl f/large-distract was broken.The repair technician reported the device was missing cotter pin and chain and also missing spring nut.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: cotter pin, chain and connecting & spring nut.The item was repaired per the inspection sheet, passed synthes final inspection on aug-19, 2021 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.  the device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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 Name
ENDPIECE WITH DOUBLE JOINT
Type of Device
TRACTION, APPARATUS, NON-POWERED
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key12396083
MDR Text Key280708161
Report Number2939274-2021-05082
Device Sequence Number1
Product Code HST
UDI-Device Identifier10886982199720
UDI-Public(01)10886982199720
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number394.44
Device Catalogue Number394.44
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2021
Date Manufacturer Received09/08/2021
Patient Sequence Number1
Treatment
ENDPIECE WITH DOUBLE JOINT; HOLDSLEEVE W/WINGSCR L105 I-Ø 6 F/LARGE-; HOLDSLEEVE W/WINGSCR L105 I-Ø 6 F/LARGE-; HOLDSLEEVE W/WINGSCR L105 I-Ø 6 F/LARGE-; HOLDSLEEVE W/WINGSCR L55 I-Ø 6 F/LARGE-D; HOLDSLEEVE W/WINGSCR L55 I-Ø 6 F/LARGE-D; RADIOLUCENT INSERTION HANDLE FRN; RED FORCEPS SERRATED JAW-RATCHET 144; RED FORCEPS POINTS ONE BENT TIP/174; REDUCTION FORCEPS POINTS RATCHET 200
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