MAUDE Adverse Event Report: ARTHREX, INC. PROXIMAL BODY, EM TIBIAL GUIDE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	PROXIMAL BODY, EM TIBIAL GUIDE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by the sales rep, that during a total knee arthroplasty, the ar-613-93, patella multi tool, would not lock into place.The rep held the ar-613-93, in place during the cementing process of the patella.The surgeon then tried to use the ar-623-30, tibal guide but, the height adjustment on the guide would not reduce down and then jammed.The case was completed using an ar-9401-14, intramedullary humeral cutting guide with no further issues.10/21/2019: update for clarification.Per lt1-0007-en total knee arthroplasty surgical technique, the ibalance tka instruments include options for resecting the tibia using extramedullary or intramedullary guidance.The ar-623-30 used was the proximal body component of the extramedullary (em) tibial guide indicating that an extramedullary surgical technique was initially pursued.Since the case was completed using the ar-9401-14 intramedullary humeral cutting guide, it is understood that the surgical technique was changed during surgery from an extramedullary to an intramedullary tibial resection.

• Brand Name: PROXIMAL BODY, EM TIBIAL GUIDE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9289993
• Report Number: 1220246-2019-01408
• Device Sequence Number: 16670341
• Product Code: LXH
• UDI-Device Identifier: 00888867224551
• UDI-Public: 00888867224551
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: PROXIMAL BODY, EM TIBIAL GUIDE
• Device Catalogue Number: AR-623-30
• Device Lot Number: 37621736
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other