MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/28MM; SCREW, FIXATION, BONE

Model Number	02.206.228
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient underwent revision surgery of a variable angle locking compression plate (va-lcp) anterolateral distal tibial plate 10 holes right due to nonunion.There were six (6) 2.7 mm variable angle locking screws removed, out of six (6) screws two (2) were broken.Also had four (4) 3.5 cortex screws that were removed as well, three (3) out of 4 screws were broken.The 2.7 mm locking compression plate 7 holes plate was removed, with that plate there were (6) 2.7mm cortex screws one (1) was broken.  the surgeon replace the tibial with another variable angle (va) anterolateral distal tibia plate.It was a 14-hole right.Ended up with a (4) cortex screws in the shaft and 5 (va) locking screw distally.There was one fragment that is non-retrievable it was the screws were incased in bone, it was not removed to avoid extensive dissection.It was left in the patient and no plan to remove.The original date of implant was on (b)(6) 2018.Other than the times it takes to remove the hardware there were no other surgical delays.All other hardware was removed completely and successfully.Procedure outcome was good.Patient was in stable condition and tolerated the procedure well.Concomitant devices reported: 2.7 mm variable angle locking screws (part# unknown, lot# unknown, quantity# 4), 3.5 cortex screws (part# unknown, lot# unknown, quantity# 1), 2.7 mm cortex screws (part# unknown, lot# unknown, quantity# 5) 2.7/3.5 mm va-lcp anterolateral distal tibia pl/10 holes/right (part# 02.118.208, lot# 7571300, quantity# 1).This is report 2 of 6 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.A device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 22-sep-2017, part number: 02.206,228, 3.5mm crtx screw/low prof hd self-tapping/star drive/28mm, lot number: h461894 (non-sterile), lot quantity: 100, work order traveler met all inspection acceptance criteria.Component part(s) reviewed: part number: 02.206.228.999, 3.6mm screw blank/ 28mm 3.5mm lw prof crtx screw w/t15 lot number: h455104, lot quantity: 960, work order traveler met all inspection acceptance criteria.Part number: 11139, 316ltcri3.58, lot number: h361198, lot quantity: 1,073 lbs.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.A product investigation was conducted.Visual inspection: the 3.5mm crtx screw/low prof hd self-tapping/star drive/28mm (p/n 02.206.228 lot h461894) was received with the threaded shaft broken off and missing.The screw head and 2 most proximal thread forms, where the transverse fracture is located, were returned.The following screw implants were returned as a concomitant device without an alleged complaint condition.P/n: unk (2.7 mm va locking) lot #: unk qty: 4, p/n: unk (2.7 mm cortex) lot #: unk qty: 5, p/n: 02.206.226 lot #: 7624795 qty: 1.Upon visual inspection, there is no evidence that these screws contributed to the complaint condition, and therefore no additional investigation will be performed on these screws.The device failure/defect of broken screw was identified during the investigation and is related to the reported complaint condition.Dimensional inspection: dimensional inspection of the threads could not be conducted as the threaded shaft is broken off and missing.The remaining thread form does not provide an accurate measurement for any thread diameters.Document/specification review: the relevant drawing, reflecting the manufactured and current revision, was reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the 3.5mm crtx screw/low prof hd self-tapping/star drive/28mm (p/n 02.206.228 lot h461894) as the threaded shaft was broken off and missing.While no definitive root cause could be determined, it is possible that condition was due to early excessive strain by patient or the screws incorrectly locked to plate (not properly torqued).During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Corrected number of reported device.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
Concomitant devices reported: 2.7mm variable angle locking screws (part# unknown, lot# unknown, quantity# 4), 3.5 cortex screws (part# 02.206.226, lot# 7624795, quantity# 1), 2.7mm cortex screws (part# unknown, lot# unknown, quantity# 5) 2.7/3.5mm va-lcp anterolateral distal tibia pl/10 holes/right (part# 02.118.208, lot# 7571300, quantity# 1).This is report 2 of 7 for (b)(4).

• Brand Name: 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/28MM
• 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: 8789255
• Report Number: 2939274-2019-59176
• Device Sequence Number: 1845566
• Product Code: HWC
• UDI-Device Identifier: 10886982051066
• UDI-Public: (01)10886982051066
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111230
• 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,Followup
• Report Date (Section B): 06/18/2019

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: 02.206.228
• Device Catalogue Number: 02.206.228
• Device Lot Number: H461894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/12/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7/3.5MM VA-LCP DISTAL TIBIA PL/10 HOLES/RIGHT; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING; 2.7/3.5MM VA-LCP DISTAL TIBIA PL/10 HOLES/RIGHT; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention