MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM CORTEX SCREW 38MM; SCREW, FIXATION, BONE

Model Number	214.038
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown when device broke.Additional procode: ktt.Lot number is unknown.Device has not been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unknown.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.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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, patient was treated with distal femur fracture system due to complex fracture.On (b)(6) 2018, patient suffered pain due to a body-height fall.Medical image examination on an unknown date indicated that there were broken screws as well as a delayed consolidation of the fracture.Revision surgery for the removal of implant and placing of a new one is currently unscheduled.Patient requested a voluntary discharge and can no longer be contacted.Concomitant devices: trauma plate (part: unknown, lot: unknown, quantity: unknown); trauma screws (part: unknown, lot: unknown, quantity: unknown).This report is for a 4.5mm cortex screw 38mm.This is report 2 of 3 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.Investigation summary: it was reported that there were broken screws following a fall from height.No product was returned; the investigation was performed based on the received medical images attached to the main complaint.Upon review of the medical images, it can be confirmed that three screws are broken in the shaft of the plate.It is unknown from the images what type of screw is broken.The cause for the breakage is not able to be determined, though a potential cause is due to the reported fall.The risk documentation was reviewed and was found to adequately address the complaint condition.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.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: 4.5MM CORTEX SCREW 38MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7861306
• Report Number: 8030965-2018-56200
• Device Sequence Number: 1431696
• Product Code: HWC
• UDI-Device Identifier: 10886982153517
• UDI-Public: (01)10886982153517
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 214.038
• Device Catalogue Number: 214.038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/08/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2017; THERAPY DATE: (B)(6) 2017
• Outcome Attributed to Adverse Event: Required Intervention