MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 13.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Model Number	352.253S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Additional classification code: hrx.Implant date is unknown.Explant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 during a left femur reaming in treatment of a distal tibia non-union, the ria system was utilized for bone grafting material and the drill heads would not advance properly.The surgeon used extreme force in reaming and felt the head was dull so another head was utilized.The same issue occurred and it was difficult to advance through the bone.The surgeon switched out the shaft and then switched back to the original shaft and head to complete the procedure.A 10-15 minute surgical delay was noted due to the difficulty in reaming.No devices broke.There was no information on the initial fracture or any hardware initially implanted.Concomitant devices.Reamer shaft (part# 314.743, lot# unknown, qty 2).This is report 2 of 2 for (b)(6).
Additional Manufacturer Narrative
Manufacturing location: (b)(4) engineering, inc., packaged by: (b)(4), manufacturing date: january 20, 2016.Expiration date: december 31, 2024.Certificate of compliance, certification of hardness for stainless steel, certificate of analysis, certificate of test and inspection sheet for incoming final inspection met specifications.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no other issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.Device is an instrument and is not implanted/explanted.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: 13.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7072666
• Report Number: 2939274-2017-50099
• Device Sequence Number: 11077711
• Product Code: HTO
• UDI-Device Identifier: 10886982194480
• UDI-Public: (01)10886982194480(17)241231(10)9957225
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

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 Expiration Date: 12/31/2024
• Device Model Number: 352.253S
• Device Catalogue Number: 352.253S
• Device Lot Number: 9957225
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR