MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MAXFRAME(TM) QUICK ADJUST STRUT/MEDIUM; APPLIANCE, FIXATION, NAIL

Model Number	03.312.812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Event or Problem Description
It was reported that during an ankle reconstruction procedure on (b)(6) 2019, the resident did not use counter torque on the maxframe quick adjust strut when tightening down with the torque limiting wrench and broke two (2) struts.Broken struts were replaced with a new strut and instructions were provided for correct tightening.There was no surgical delay.Procedure was successfully completed with no surgical delay.Patient outcome is unknown.Concomitant devices reported: unknown torque device (part# unknown, lot# unknown, quantity# 1).This report is for one (1) maxframe (tm) quick adjust strut/medium.This is report 2 of 2 for complaint (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.H10 additional narrative: h3, h6: part: 03.312.812; lot: h563012; release to warehouse: (b)(6) 2018 ¿ (b)(6)2018; manufacture site: brandywine plant; expiration date: n/a.Device history record (dhr) review completed for lot h563012 of assembled quick adjust struts, no nonconformances found.The dhr shows that this lot of strut tubes was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.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.Based on dhr review and pictures of broken parts, quality engineer decided to expand the review to include the threaded rods used in this lot (i.E., h520981).Part: 03.312.812.3; lot: h520981; date of manufacture: december 03, 2017 ¿ december 06, 2017; place of manufacture: depuy-synthes brandywine; part expiration date: n/a; list of nonconformances: n/a.Dhr review completed for lot h520981 of threaded rods; no nonconformances found.The dhr shows that this lot of threaded rods was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional, surface finish, visual, and certification criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the component "clevis for threaded rod" (part 03.312.810.15) is separated from the component "threaded rod" (part 03.312.812.3).The section of the assembly containing the 2 clevis components were not returned with the product.The component "threaded rod" (part 03.312.812.3) is broken at the point where the diameter reduces to ø3.14 and the component "pin" (part 03.312.810.16) is installed to retain the component "clevis for threaded rod" (part 03.312.810.15).The approximately 5mm-long piece of the threaded rod that was broken off was not returned with the product.Documentation/specification review: the following design drawings were reviewed.Top level assembly drawing for maxframe strut-quick adjust.Top level drawing for threaded rod - quick adjustment strut).No nonconformances or documentation changes related to the complaint condition.Functional inspection: description of functional inspection: the strut was extended/retracted through its full range of length.Additional functional inspections could not be performed due to the product being broken.The ability to fully retract/extend the strut through its full range of length was not affected by the complaint condition.Dimensional inspection: the diameter measures within the specification listed on drawing.Dhr and raw material review: dhr review completed for lot h520981 of threaded rods, no nonconformances found.The dhr shows that this lot of threaded rods was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Raw material review: a review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional, surface finish, visual, and certification criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Conclusion: the complaint condition of "broken" was confirmed, as it matches the reported condition, but upon further analysis it was determined not to be related to the manufacturing process for the following reason: there were no nonconformances during the production of the compliant products.The product passed all inspection criteria and was found to be within specifications at the time it was released to the warehouse as well as during an additional inspection performed on the broken device in this product investigation.The inspection process for the complaint product numbers includes a 100% functional inspection, and no nonconformances related to the complaint condition were present for the complainant lot.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety 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.
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.H11 corrected data: h4: date of manufacture is a range from january 30, 2018 ¿ february 14, 2018.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: MAXFRAME(TM) QUICK ADJUST STRUT/MEDIUM
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8430076
• Report Number: 2939274-2019-57016
• Device Sequence Number: 19580570
• Product Code: KTT
• UDI-Device Identifier: 10886982261038
• UDI-Public: (01)10886982261038
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K161417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.312.812
• Device Catalogue Number: 03.312.812
• Device Lot Number: H563012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019; 04/11/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/11/2019; 04/12/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION.