MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 30MM; SCREW, FIXATION. BONE

Model Number	214.830
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient dob & weight not provided for reporting.Date unknown when device malfunctioned.Complainant part was returned for manufacturer review/investigation additional info: k974537 ktt patient code used for: the patient experienced nonunion and a broken screw requiring revision surgery.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 product is entering the complaint system.Dhr review could not be conducted due the insufficient information¿s.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
It was reported that the patient had original surgery on unknown date for treatment of a humeral fracture.Patient was implanted with one (1) 4.5mm narrow (lcp)locking compression 9 hole/170mm plate and four (4) 4.5mm cortex self tapping 30mm screws.On an unknown date post-operatively, patient presented with a non-union.On (b)(6) 2018, surgeon removed implants and revised the patient to 8-hole plate and screws.At the beginning of the procedure, one (1) of the 4.5mm screws was reported as broken.The distal shaft portion of this 4.5mm cortex screw was left in the patient¿s humeral bone.Surgeon chose not to retrieve the broken screw shaft portion.Revision surgery was completed successfully with a 5-10-minute time delay due to the broken shaft tip.Patient is reported in stable condition.Sales consultant has no more information to report on this event.Concomitant device report: [unknown stryker hand drill] (part #: unknown, lot #: unknown, quantity: 1).(b)(4) is for 4.5mm cortex screw breaking post-implant and (b)(4) was opened for the tip of the ria breaking intraoperatively.This complaint is for one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional device product code: ktt.Part of the screw remained in the patient¿s bone; device not considered explanted.Date device received to manufacturer is reported inadvertently on the initial medwatch.Complainant device is not expected to be returned for manufacturer review/investigation; as such device received date is not 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 SELF-TAPPING 30MM
• 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: 7403788
• Report Number: 2939274-2018-51510
• Device Sequence Number: 1769050
• Product Code: HWC
• UDI-Device Identifier: 10886982154644
• UDI-Public: (01)10886982154644(10)LOTUNK
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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: 214.830
• Device Catalogue Number: 214.830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/07/2018
• 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
• Patient Age: 71 YR