MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/20MM; SCREW,FIXATION,BONE

Model Number	02.118.520
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device history (lot): manufacturing location: (b)(4), manufacturing date: jun 05, 2019, part number: 02.118.520, 2.7mm metaphyseal scr slf-tpng w/t8 strdrv recess 20mm, lot number: 3l33979 (non-sterile), lot quantity: (b)(4).Three pieces were scrapped in cell at (b)(4), turn head/cut to length/nose turn after being dropped.Work order traveler met all inspection acceptance criteria apart from the three pieces noted.Inspection sheet, in process/inspect dimensional/final inspection, (b)(4) met all inspection acceptance criteria.Packaging label log (pll) lppf, lmd was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of removed due to the screw cold-welded to the plate does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Dhr reviewed: dec 23, 2020.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, a removal surgery was performed due to a defective femoral neck system.The locking screw cold welded to the femoral neck system (fns) plate.The original implantation date was unknown.The procedure and patient outcome were unknown.This complaint involves two (2) devices.This report is for (1) 2.7mm metaphyseal scr slf-tpng w/t8 stardrive recess/20mm.This report is 2 of 2 for (b)(4).
Additional 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.H10 additional narrative: h3, h6: visual inspection: the 2.7mm metaphyseal scr slf-tpng w/t8 strdrv recess/20mm was received at us customer quality (cq).Visual inspection of the complaint device showed the head of screw was bent inward and missing small pieces.The device was received disassembled from the mating device.Functional test: a functional assessment was unable to be performed on the complaint device due to device damage.However, the damage is indicative of the complaint condition of unable to disassemble, since the screw was possibly drilled out of the mating plate.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the device has damage indicative of the complaint condition of unable to disassemble and is missing small pieces.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.H5.

• Brand Name: 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/20MM
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11156496
• Report Number: 2939274-2021-00228
• Device Sequence Number: 19850912
• Product Code: HWC
• UDI-Device Identifier: 10886982039262
• UDI-Public: (01)10886982039262
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: 02.118.520
• Device Catalogue Number: 02.118.520
• Device Lot Number: 3L33979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/03/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIROTATION SCREW F/ FNS 100MM LENGTH - STER; BOLT FOR FEMORAL NECK SYSTEM 95MM LENGTH-STERILE; FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE