MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE, FIXATION, BONE

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Date of event: date of post-operative pain development is unknown.This report is for one (1) unk - plates: dhs/dcs, part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Complainant part is not expected to be returned for manufacturer review/investigation.Device was used for treatment, not diagnosis.

Event Description

It was reported that the patient complained of pain and wanted the fracture to heal.The patient initially had a hip surgery procedure with a dynamic hip screw (dhs) implant on (b)(6) 2017.The implant was in the iliotibial (it) band on the lateral side because of the collapse done with the fracture.A revision surgery was performed on (b)(6) 2018, wherein the initial dhs implant was removed and revised to a smaller lag screw and a 70mm 4-hole side plate.The explanted plate along with the lag screw was intact.It is unknown if there was a surgical delay.There was no mentioned of a procedure and patient outcome.This complaint involves two (2) devices.This complaint is for 1 unk plate: dhs/dcs.This report is 1 of 2 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7935815
• MDR Text Key: 122792604
• Report Number: 2939274-2018-54166
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 58