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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11130742
• Report Number: 2939274-2021-00035
• Device Sequence Number: 16301601
• Product Code: JDO
• UDI-Device Identifier: 10886982177551
• UDI-Public: 10886982177551
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 281.520S
• Device Catalogue Number: 281.520S
• Device Lot Number: H807562
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention