MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM CANNULATED LOCKING SCREW 80MM; SCREW, FIXATION, BONE

Model Number	02.205.080
Medical Device Problem Codes	Material Twisted/Bent (2981); Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an unknown date in 2018.Additional procodes: hty, jdw, hrs.Date of implantation is an unknown date in (b)(6) 2018.Concomitant medical products: date of concomitant therapy is the same as date of implantation, an unknown date in (b)(6) 2018.Manufacturing location: (b)(4); manufacturing date: august 12, 2017; part: 02.205.080; 5.0mm cannulated locking screw 80mm; lot: h418023 (non-sterile); lot quantity: (b)(4) work order traveler met all inspection acceptance criteria.Inspection sheet, inspect turn/wobble broach, mill shaft threads/head threads/flutes and final inspection met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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.Device evaluation investigation flow: device interaction/functional.Visual inspection: the 5.0 mm cannulated locking screw 80 mm was returned to us customer quality.Upon visual inspection under 5x magnification, damages were observed on the threads of the shaft as well as the screw head, which is consistent with implantation and explantation which would not impact the device functionality.X-rays were not provided, hence there is no definitive means to show/determine that the screw backed out/ migrated.As such, the complaint cannot be confirmed.Replication of the complaint is not possible as the locking plate was not returned.As such, the reported condition cannot be confirmed.However, the overall complaint is confirmed as there are post manufacturing damages.Document/specification review the following relevant drawings were reviewed.- 5.0 mm locking screw cannulated review of the device history record (dhr) showed that 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.Dimensional inspection dimensional inspection of the screw was performed.The returned screw was determined to be suitable for its intended use when employed as recommended.The head diameter of the screw measured 6.60 mm.This is within specifications of 6.61 mm ± 0.1 based on drawings.The shaft diameter (threaded portion) measured 4.96 mm.This is within specifications of 5.0 mm ± 0.1 based on drawings.All measurements were taken using caliper ca 122 p.Conclusion: the reported complaint condition is not confirmed as there was no x-ray sent to us cq showing the backed out/migrated screw.However, visual inspection revealed damages on the threads of the shaft as well as the screw head.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Risk assessment review: a risk assessment review was performed.The complaint is adequately addressed by the risk assessment.(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 a patient underwent a removal surgery on (b)(6) 2018.One (1) 70mm cannulated variable angle (va) locking screw, one (1) 75mm cannulated va locking screws, two (2) 80mm cannulated va locking screws and one (1) 85mm cannulated va locking screw had backed out of the condylar plate and were removed.The plate was retained, and new screws were added.The variable angle locking compression plate (lcp) condylar plate was originally implanted on (b)(6) 2018.Procedure outcome and patient status is unknown.Concomitant devices: condylar plate (part: unknown, lot: unknown, quantity 1), locking spine screw (part: unknown, lot: unknown, quantity 1).This report is for a 5.0mm cannulated locking screw 80mm.This is report 5 of 5 for (b)(4).

• Brand Name: 5.0MM CANNULATED LOCKING SCREW 80MM
• 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: 8272078
• Report Number: 2939274-2019-56027
• Device Sequence Number: 16568802
• Product Code: HWC
• UDI-Device Identifier: 10886982049780
• UDI-Public: (01)10886982049780
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K000066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/25/2018

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
• Operator of Device: Health Professional
• Device Model Number: 02.205.080
• Device Catalogue Number: 02.205.080
• Device Lot Number: H418023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 01/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 117