MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; STEM EXTRACTOR THREADED

Catalog Number	01-003-10-0002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: (cn: 161-00-06, sn: unk) slap hammer adapter 1/4-20.
Event or Problem Description
As reported, during a hip revision on (b)(6) y/o male patient¿s left tha 8 yrs postop, the surgeon began threading the extraction tool to the femur and it would not seat fully.He said he did to the best he could with cleaning out the existing tissue.It was mentioned that with the extraction device not being fully seated, he needs to be carefully.He attached the slap hammer and made multiple attempts to test and see if the femur would come out.After his fifth or sixth time, the threaded extraction tip broke off and remained threaded into the stem.He then attempted to remove the stem with the trunnion extraction instrument attached to the slap hammer.After numerous attempts the surgeon stated, "at least i tried to remove it".Removal of the stem was not discussed, only trying to test stability.The surgeon left the stem and swapped out the femoral head with a new head and collar.The broken threaded tip remained in the patient and surgeon did not appear concerned.Patient was last known to be in stable condition following the event.Broken knee instrument to be retuned.Knee instrument to be retuned under (b)(4).This case will capture the malfunction and the revision will be captured in case-(b)(4).
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the event was likely the result of applying a bending moment to the slap hammer/slap hammer adapter that was not fully seated in the femoral stem due to biological material being retained in the femoral stem¿s internal threads.The incomplete seating of the devices likely resulted in ultimate fracture of the slap hammer adapter¿s threads.Concomitant: (cn: 161-00-06, sn: unk) slap hammer adapter 1/4-20 no information provided in the following section(s): a4, a5, b6, the following section(s) have additional info: d4 (lot number) g4, g7, h1, h2, h3, h7.

• Brand Name: EXACTECH
• Common Device Name: STEM EXTRACTOR THREADED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10549722
• Report Number: 1038671-2020-00523
• Device Sequence Number: 3033756
• Product Code: LXH
• UDI-Device Identifier: 10885862267146
• UDI-Public: 10885862267146
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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 Catalogue Number: 01-003-10-0002
• Device Lot Number: 160823001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR