MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND DYNAFORCE DYNABUNION; PLATE, FIXATION, BONE

Model Number	15LP-3536
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon reported that the patient's anti-drift bolt (adb) backed out.The patient originally had lapidus surgery with dynabunion plate and adb on (b)(6) 2020.The patient also had a talonavicular fusion with crossroads staples, plates and screws.The adb was replaced with another screw on (b)(6) 2021.Other hardware was not revised.
Additional Manufacturer Narrative
The surgeon reported that the patient's anti-drift bolt (adb) backed out.The patient originally had lapidus surgery with dynabunion plate and adb on (b)(6) 2020.The patient also had a talonavicular fusion with crossroads staples, plates and screws.The adb was replaced with another screw on (b)(6) 2021.Other hardware was not revised.Non-conformance was not identified based on the lots that would contribute to these events.Screw back-out may have been due to inadequate fixation intra-operatively.The following screws and plates were implanted with the adb and not revised or removed: ref: 7100-lp18-r ln: 501209 qty: 1 product name: dynabunion plate 18mm - right.Ref: 1500-3514 ln: 400032 qty: 1 product name: motoband non-locking screw 3.5mm x 14mm.Ref: 1500-3516 ln: 400083 qty: 1 product name: motoband non-locking screw 3.5mm x 16mm.Ref: 15pl-3514 ln: 450132 qty: 1 product name: motoband polyaxial locking screw 3.5mm x 14 mm.Ref: 7118-1818 ln: 501144 qty: 1 product name: 18x18x18mm himax.

• Brand Name: MOTOBAND DYNAFORCE DYNABUNION
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• MDR Report Key: 11952200
• Report Number: 3011421599-2021-00009
• Device Sequence Number: 13718059
• Product Code: HRS
• UDI-Device Identifier: 00815432028825
• UDI-Public: 00815432028825
• Combination Product (Y/N): N
• PMA/510(K) Number: K193452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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 Expiration Date: 07/17/2022
• Device Model Number: 15LP-3536
• Device Catalogue Number: 15LP-3536
• Device Lot Number: 501167
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR