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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - BONE STAPLE: ELITE; STAPLE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - BONE STAPLE: ELITE; STAPLE, FIXATION, BONE Back to Search Results
Catalog Number UNK - BONE STAPLE: ELITE
Device Problem Device-Device Incompatibility (2919)
Patient Problem Pain (1994)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).This report is for an unk - bone staple: elite/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.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 the usa as follows: it was reported on an unknown date, the surgeon was reported that the patient was revised due to some painful hardware, the revision happens in more than 1 occasion.Two of the patient that was the cci implant, 4 leg elite continues compress the implant and it was very difficult to remove which resulted in (____) to the patient and 1 procedure where the surgeon cut the implant and the patient retained the leg of the cci implant.Patient and procedure involvement is there.This complaint involves one (1) device unk - bone staple: elite.This is report 1 of 1 for complaint (b)(4).
 
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Brand Name
UNK - BONE STAPLE: ELITE
Type of Device
STAPLE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14340813
MDR Text Key291371874
Report Number2939274-2022-01682
Device Sequence Number1
Product Code JDR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK - BONE STAPLE: ELITE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2022
Initial Date FDA Received05/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
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