MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.3MM CANNULATED SCFE SCREW 20MM THREAD/65MM; SCREW, FIXATION, BONE

Model Number	02.207.619
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.No patient information was available for reporting it is unknown when the screw broke.Original implant date unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a hardware removal procedure occurred on (b)(6) 2018 due to a broken slipped capital femoral epiphysis (scfe) screw.The broken screw was removed and no fragments left behind in the patient.It was noted the screw broke at the base of the threads.No surgical delay was noted.Patient status is unknown.This is report 1 of 1 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.Additional narrative: lot number: this information is now known.Product has been received.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history records review has been requested.Corrected data: brand name and catalog.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.
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.A device history record (dhr) review was performed for part#02.207.622, lot#7946920: manufacturing location: supplier mark two engineering, manufacturing date: 14.May.2015.No non-conformance reports (ncrs) were generated during production.The material was determined to be conforming at the time of manufacture based on review of the dhr.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was conducted: the returned implant is part of the slipped capital femoral epiphysis screw system.The implants are utilized for femoral neck fractures, slipped capital femoral epiphysis, tibial plateau fractures, ankle arthrodesis, intercondylar fractures, sacroiliac joint disruptions, and subtalar arthrodesis per relevant technique guide.The following investigation flow was performed: broken.The implant was returned with the distal threads broken off from the rest of the screw (not returned) which agrees with the complaint condition.Visual inspection shows the fracture to be transverse.The head of the screw shows wear marks indicating the screw was implanted and removed.The complaint conditioned is confirmed.A root cause could not be determined as the circumstances surrounding the complaint are unknown a device history review, including material review, was performed for the returned instrument¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture).The design, materials and finishing processes were found to be appropriate for the intended use of this device.The measurements of the returned damaged screw indicated that it was manufactured according to specifications.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device has no material hardness specification.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.

• Brand Name: 7.3MM CANNULATED SCFE SCREW 20MM THREAD/65MM
• 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: 7437482
• Report Number: 2939274-2018-51772
• Device Sequence Number: 19243079
• Product Code: HWC
• UDI-Device Identifier: 10886982052483
• UDI-Public: (01)10886982052483
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2018

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: 02.207.619
• Device Catalogue Number: 02.207.622
• Device Lot Number: 7946920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 05/07/2018; 05/25/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/22/2018; 05/25/2018
• 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