MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; SCREW,FIXATION,BONE

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: endrizzi, d.Et al (2016) nonunion of the clavicle treated with plate fixation: a review of forty-seven consecutive cases, journal of shoulder and elbow surgery volume 17 (6) november¿december 2008, pages 951-953 (usa).This retrospective study aims to evaluate the outcome of clavicular plating on the superior surface of the clavicle.The secondary purpose was to determine whether autogenous bone graft is necessary when treating nonunions of the clavicle.Between 1995 and 2005, 47 patients (33 male 14 female) with a mean age of 38.7 years (range, 12-68 years) with symptomatic, painful nonunions treated with open reduction and internal fixation (orif) via a plate applied superiorly were included in the study.Of these patients,there were 45 patients with sufficient follow-up to assess union.27 patients were treated with curved pelvic reconstruction plates, 16 patients with straight pelvic reconstruction plates or locking pelvic reconstruction plates, and 4 patients with straight dynamic compression plates (synthes, paoli, pa).The patients were followed up regularly until union was achieved.The following complications were reported as follows: 2 patients treated with a dynamic compression plate required second surgery due to implant loosening.1 patient treated with a pelvic reconstruction plate required second surgery due to implant loosening.10 patients had hardware removal due to plate prominence or sensitivity non-union- 2 patients had transient upper extremity paresthesias that resolved by 6 weeks postoperatively.6 patients had numbness around the incision.1 patient developed supraclavicular neuroma.Death- this report is for an unknown synthes screw.This is report 4 of 6 for (b)(4).Due to a limit of impacted products per complaint, this complaint will be captured under 2 separate complaints: (b)(4).For the overall complaint, adverse event review activity, mdv activity, and additional information request activity will be documented in (b)(4).

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.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.

• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8667211
• MDR Text Key: 146946074
• Report Number: 2939274-2019-58441
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention