MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 135 DEG DHS PLATE-SHORT BARREL 2 HOLES/46MM-STERILE; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Model Number 281.520S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Released to warehouse: 06-feb-2019.Expiration date: 31-dec-2027.Part number: 281.520s, 135 deg dhs plate-short barrel 2 holes/46mm-sterile.Lot number: h807562 (sterile).Lot quantity 24.This dhr review is for monument operations only: thermal rinse, packaging / labeling, sterilization and release work order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.(b)(4) was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) 2020 the patient underwent a hardware removal of the dynamic hip system (dhs) from the left femur due to the patient's age.The plate, lag screw, and (2) 4.5 cortex screws were removed without issues.The procedure was successfully completed.There was no surgical delay reported.Patient outcome was unknown.This report is for one (1) 135 deg dhs plate-short barrel 2 holes/46mm-sterile.This is report 2 of 4 for (b)(4).

• Brand Name: 135 DEG DHS PLATE-SHORT BARREL 2 HOLES/46MM-STERILE
• Type of Device: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11130742
• MDR Text Key: 225496043
• Report Number: 2939274-2021-00035
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 10886982177551
• UDI-Public: 10886982177551
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 281.520S
• Device Catalogue Number: 281.520S
• Device Lot Number: H807562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention