MAUDE Adverse Event Report: EXACTECH, INC. SHLDR GPS IMPACT HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SHLDR GPS IMPACT HANDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	01/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that the ball bearing and spring from the gps glenoid impactor handle dislodged inside of patient when the surgeon impacted the glenoid baseplate.The surgeon became aware when the spring was located during the case.Post op ap x ray taken shows no ball bearing left in the patient.There was less than a 5 minute surgical delay.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: per capa2021-02, the disassembly issue reported was likely the result of the retaining feature tolerances on the engineering drawing not being sufficiently robust and internal bore dimensions requiring an inspection method that may have contributed to damage.Additionally, improper machining of the bore by the vendor resulted in an out of specification condition that allowed the retaining ball to become disassociated from the shaft of the device during use.

• Brand Name: SHLDR GPS IMPACT HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13476909
• Report Number: 1038671-2022-00180
• Device Sequence Number: 17414441
• Product Code: LXH
• UDI-Device Identifier: 10885862542038
• UDI-Public: 10885862542038
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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: SHLDR GPS IMPACT HANDLE
• Device Catalogue Number: 531-07-05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2019
• 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 Age: 75 YR
• Patient Sex: Female