MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. HUMERAL REAMER GUIDE BODY DEF. STD MOD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DGB096008STD
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a reverse shoulder system-s procedure, the plastic insert of a humeral reamer guide body def.Std mod broke off in bone.Surgery was resumed after a non-significant delay.It is unknown how the procedure was completed.The patient outcome is unknown.
Additional Manufacturer Narrative
G3: this event occured on the 8-aug-2022.
Additional Manufacturer Narrative
Results of investigation: the product has not been received at the aus site for evaluation and photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed: complaint history review: the complaint history review identified no similar reported events for this device.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.The complaint alleges no injury to the patient nor a delay during surgery.It was determined that the device likely contributed to the reported event as the most probable cause of the failure was wear and damage due to normal use.The rss humeral reamer guide body is a reusable instrument expected to be used across multiple surgeries.Its intended use is to guide the reaming of the proximal humerus during bone preparation.The definitive stem reamer guide body is specifically used when converting a patient from an anatomic shoulder to a reverse shoulder.The guide body features a plastic collar which fits over and protects the existing stem taper during the reaming.The guide body is impacted in place to secure the plastic collar over the existing stem taper.Therefore, the plastic collar of the device may fail after prolonged use or if subjected to excessive force, such as during impaction or reaming.Based on this investigation, the need for corrective action is not indicated as no non-conformances nor manufacturing deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.

• Brand Name: HUMERAL REAMER GUIDE BODY DEF. STD MOD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15349604
• Report Number: 3002788818-2022-00062
• Device Sequence Number: 12085483
• Product Code: LXH
• UDI-Device Identifier: 10381780244493
• UDI-Public: 10381780244493
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DGB096008STD
• Device Catalogue Number: DGB-0960-08STD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022; 10/10/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/13/2022; 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown