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

Model Number	03.312.812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 while doing a maxframe strut swap, the new strut being put on and torqued broke.There was no harm to the patient.Another strut was used and the procedure was completed successfully with no surgical delay reported.This report is for one (1) maxframe(tm) quick adjust strut/medium.This is report 1 of 1 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.H10 additional narrative: h3, h6: part: 03.312.812-us.Lot: 3l34394.Manufacture date: may 29, 2019.Manufacturing location: brandywine.Part expiration date: n/a.No relevant nonconformances were noted.A review of the device history record of this lot revealed no complaint-related anomalies.The maxframe quick adjust strut met all assembly, inspection, and pack/label criteria at the time of release with no issues documented that would contribute to this complaint condition.Visual inspection: the max frame (tm) quick adjust strut/medium was received at us customer quality (cq).Upon visual inspection, the component "threaded rod" (part # 03.312.812.3) of the returned device was broken at the point where the pin locks the clevis into position and the threaded rod was stuck in the broken piece.No other issues were identified with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint-relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/ specification review: the following current and manufactured revisions were reviewed.Strut.Threaded rod.Investigation conclusion: the complaint condition was confirmed for the returned device.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces during its use.No new malfunctions were observed during this investigation.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.G1.

• Brand Name: MAXFRAME(TM) QUICK ADJUST STRUT/MEDIUM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12181844
• Report Number: 2939274-2021-04139
• Device Sequence Number: 10990323
• Product Code: KTT
• UDI-Device Identifier: 10886982261038
• UDI-Public: 10886982261038
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: No Information
• Device Model Number: 03.312.812
• Device Catalogue Number: 03.312.812
• Device Lot Number: 3L34394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/16/2021
• Patient Sequence Number: 1