Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PIN, FIXATION, SMOOTH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PIN, FIXATION, SMOOTH Back to Search Results
Device Problem Migration (4003)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown hammerlock 2 bone staple /unknown lot.Part and lot number 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.(b)(4).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 an unknown date, that the hammerlock original has to be removed due to cutting out of bone.Future removal date is unknown.The device was originally implanted on (b)(6) 2018.Patient status is unknown.This report is for an unknown hammerlock 2 bone staple.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
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.Investigation summar us customer quality investigation performed by manufacturer.Devices were not returned, manufacturing investigation based on image received in attachment "(b)(4) intake email from sales consultant 5mar2019".Manufacturing investigation (reference action (b)(4)).Investigation consisted on analysis of the x-ray image provided by sales consultant.Based on this analysis the complaint condition could be confirmed (broken implant and migration).Implants shown on x-rays are both hammerlock 1.0 and not hammerlock 2 as originally stated by the complaint.This can be told based on the proximal ends of the implant that show two separate ¿legs¿ compressed together inside the bone, compared to hl2 which presents two distal legs and an ¿arrow head¿ with two ¿wings¿ on the proximal side of the implant with another pair of wings located at the center, refer to attached drawings in pi.Hammerlock 1.0 was taken off the market on 2013, superseded by hammerlock 1.1, which was later superseded by hammerlock 2 in 2016.Reference attachment - hammerlock configurations." the fractures presented in the x-rays provided are fatigue fractures, which are commonly caused by load bearing or physical malformations of the bone.In this case, patient information is unknown therefore it is not possible to determine if the patient followed proper care after implantation.The x-rays show mallet toe malformation in four of the toes of the patient, which could also be a contributing factor for implant breakage and the implant coming out of the bone.(reference medical opinion action (b)(4)).Root cause for implant break and implant migration out of the bone cannot be determined based on the information provided in the complaint.No manufacturing related issues were identified and/or confirmed during x-ray analysis, therefore review to the specific prm and prm line is not required.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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.
 
Manufacturer Narrative
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.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
Further it was reported that reported that on (b)(6) 2019, the surgeon attempted to remove the hammerlock original but the surgeon could not get the bases out and the other parts broke off so he amputated the toes of the patient.Patient status is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
PIN, FIXATION, SMOOTH
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8462011
MDR Text Key140275558
Report Number2939274-2019-57168
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 03/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/03/2019
Initial Date FDA Received03/28/2019
Supplement Dates Manufacturer Received05/02/2019
05/02/2019
Supplement Dates FDA Received05/02/2019
05/02/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-