MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CANNULATED SCREW PARTIALLY THREADED/64MM; SCREW, FIXATION, BONE

Model Number	207.634
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary 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.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.(b)(4).
Event or Problem Description
This report is being filed after the review of the following journal article: murawski, c.D., thread delamination in 4.5 mm ao cannulated screws: a small case series in the pediatric trauma population, vol.Xx (xx), pages 1-14 (usa).The aim of this retrospective study is to report the occurrence of repeated hardware failures via thread delamination in the setting of a commonly used orthopaedic cannulated screw implant in a small cohort involving pediatric fracture care at a single academic level i trauma center.Between august 2015 to january 2020, a total of 8 patients who had hardware failure associated with 4.5 mm ao cannulated stainless-steel screws (depuy synthes companies, johnson & johnson medical devices; warsaw, in) were identified.3 patients were excluded leaving a total of 5 patients (1 male and 4 female) with a mean age of 13.8 years (range, 12-15 years) were included in the study.Surgery was performed using a 4.5 mm ao cannulated screws, of which 4 partially threaded screws and one was a fully threaded construct.The follow-up duration was unknown.The following complications were reported as follows: 3 patients who were excluded in the study had a hardware failure.Two of these patients did not involve delamination.One involved failure at the screw head, which fractured during hardware removal of a medial humeral epicondyle fracture, and another broke at the level of the self-tapping flute during screw insertion to a proximal fifth metatarsal fracture.A third case was discrepant as to whether it truly involved delamination of the thread or whether a piece of the drill bit had fractured.A (b)(6) year old female patient had partial proximal thread delamination, of which the thread was retained.A (b)(6) year old female patient had partial distal thread delamination, of which the thread was retained.A (b)(6) year old female patient had complete thread delamination into the tibiotalar joint requiring anterior arthrotomy.A (b)(6) year old female patient had partial distal thread delamination, of which the thread was retained.A (b)(6) year old male patient had partial distal thread delamination, of which the thread was retained.This impacted product captures the reported (b)(6) year old female patient who had complete thread delamination into the tibiotalar joint requiring anterior arthrotomy.This report is for an unknown synthes 4.5 mm cannulated screws.This report is 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 CANNULATED SCREW PARTIALLY THREADED/64MM
• 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: 9993082
• Report Number: 2939274-2020-02012
• Device Sequence Number: 11687555
• Product Code: HWC
• UDI-Device Identifier: 10886982148216
• UDI-Public: (01)10886982148216
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 207.634
• Device Catalogue Number: 214.564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 04/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention