MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM; SCREW, FIXATION, BONE

Model Number	02.211.040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Skin Irritation (2076); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown when the event occurred.This report is for a blade impactor - unknown lot.Additional procodes: hrs.Complainant part has not been returned for manufacturer review/investigation.Initial reporter: unknown.(b)(4).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
It was reported that a patient underwent revision of one (1) 2.7 mm variable angle (va) locking screw in the left elbow on (b)(6) 2018 since it was prominent through the skin and caused pain to the patient.The patient was implanted initially with a left elbow construct consisting of two (2) unknown plates and unknown quantity of screws on (b)(6) 2017 for an unknown fracture.Subsequently, the patient noticed that one (1) of the screws was prominent and that it could be felt on the skin.The patient also was in pain due to the same.This was also reported to be evident in the post-operative follow-up x-rays (unavailable) taken on an unknown date.Hence, the surgeon decided to revise the screw with another similar screw.The revision surgery was completed successfully, uneventfully and without any surgical delay.The patient was reported to be in good health at the end of the surgery.This complaint involves one (1) device.This is report 1 of 1 for (b)(4).This report is for a screw.Concomitant devices reported: unknown plates (part# unknown, lot# unknown, quantity# 2); unknown screws (part# unknown, lot# unknown, quantity# unknown).
Additional Manufacturer Narrative
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 the patient was implanted initially with a left elbow construct consisting of two (2) unknown plates and unknown quantity of screws on (b)(6) 2017 for an unknown fracture.Subsequently, the patient noticed that one (1) of the screws was prominent and that it could be felt on the skin.The patient also was in pain due to the same.This was also reported to be evident in the post-operative follow-up x-rays (unavailable) taken on an unknown date.Hence, the surgeon decided to revise the screw with another similar screw.Patient underwent revision of one (1) 2.7 mm variable angle (va) locking screw in the left elbow on (b)(6) 2018.The revision surgery was completed successfully, uneventfully and without any surgical delay.The patient was reported to be in good health at the end of the surgery.This complaint involves one (1) device.This is report 1 of 1 for (b)(4).This report is for a screw.Concomitant devices reported: unknown plates (part# unknown, lot# unknown, quantity# 2); unknown screws (part# unknown, lot# unknown, quantity# unknown).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM
• 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: 7342363
• Report Number: 2939274-2018-51077
• Device Sequence Number: 1103321
• Product Code: HWC
• UDI-Device Identifier: 10886982053718
• UDI-Public: (01)10886982053718(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.211.040
• Device Catalogue Number: 02.211.040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 03/29/2018
• 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: 56 YR
• Patient Weight: 62