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 Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: patient information is unknown.(b)(6).The device was 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 on an unknown date during routine incoming inspection, the maxframe with quick adjust was broken.There was no patient involvement.This complaint involves one (1) device.This is 1 of 1 for report (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.H3, h6: part: 03.312.812, lot: h512615, date of manufacture: november 27, 2017, place of manufacture: brandywine plant, part expiration date: n/a (nonsterile).The device history record(s) showed that there were no nonconformances or issues during the manufacture of the product 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 component "threaded rod" (part 03.312.812.3) is broken at the point where the diameter reduces 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.Functional test: 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.Results of functional inspection pass - the ability to fully retract/extend the strut through its full range of length was not affected by the complaint condition.Dimensional inspection: using an optical comparator, the ø3.14 diameter of the section of the threaded rod where the break occurred was dimensionally inspected.Results of dimensional inspection pass - diameter measures within the specification listed on drawing (top level drawing for threaded rod - quick adjustment strut).Document/ specification review: process risk management , manufacturing inspection sheet , manufacturing visual standard for inspection of product , top level assembly drawing for maxframe strut-quick adjust , top level drawing for threaded rod - quick adjustment strut , manufacturing inspection sheet.No nonconformances or documentation changes related to the complaint condition.Investigation 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 complaint 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 per brandywine inspection includes a 100% functional inspection, and no nonconformances related to the complaint condition were present for the complainant lot.A definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however, no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique, or different patient harms were identified because of this evaluation.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.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: 9812803
• Report Number: 2939274-2020-01196
• Device Sequence Number: 609866
• Product Code: KTT
• UDI-Device Identifier: 10886982261038
• UDI-Public: (01)10886982261038
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 02/13/2020

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: H512615
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAXFRAME(TM) QUICK ADJUST STRUT/MEDIUM