MAUDE Adverse Event Report: SYNTHES (USA); REAMER

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/18/2014

Event Type  Injury  

Manufacturer Narrative

Patient code: it is unknown if the reamer fragment was retained in the patient¿s bone but for cautionary purposes, this event is being reported as an adverse event, as well as a product malfunction.Additional information has been requested and will be reported in a supplemental report if received.This report is for one unknown reamer.Part and lot numbers were available for reporting.Other number¿udi: unknown part number.Udi is unavailable.Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2014, a portion of an unknown reamer broke off inside the patient's right femur while the surgeon was using a flexible intramedullary reamer to widen the femoral canal.This event occurred during a right lateral total hip replacement procedure.It is unknown if the reamer fragment was retained in the patient's bone.This report is for one unknown reamer.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Patient initials, age, dob provided.Updated information: complaint re-opened, alert date 4/27/16; an email was received from william essig/attorney with medical records, pmh, tests, hospital info and event description.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 Description

Complaint re-opened, alert date 4/27/16, update: hospital medical records were received; a (b)(6) female patient complained of moderate to severe right hip pain.On (b)(6) 2014, the patient had a right total hip replacement (thr) procedure; all trial hardware was removed.During the procedure, it was noted the reamer tip had dislodged in the femoral canal.A cortical window was made to remove the tip.The patient was implanted with depuy pinnacle cup, corail stem 8, and femoral head.Medical history included: chronic sinusitis s/p functional endo-scopic sinus surgery ((b)(6)), drug allergy, deviated nasal septum, allergic rhinitis, otalgia, foot sprain, lumbar region disc disorder, ossteoarthrosis, chole-cystectomy, sinus surgery, other-cystoscopy negative, cystoscopy-ureteral stent inserted.Radiographs and tissue pathology were done on (b)(6) 2014.The patient was discharge to rehab, ambulating 12 feet, right toe touch weight bear (ttwb) and rolling warker (b)(6) 2014.

Manufacturer Narrative

No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable.A dhr review could not be performed as no lot# was identified.No images or visual evidence that a reamer head was stuck in a femoral canal was able to be found in the 5 cds.Therefore, this complaint is unconfirmed.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 Description

On 5/31/2016 update: medical records received; the patient with complaints of moderate to severe right hip pain.She was diagnosed with degenerative joint disease (djd) right hip and was s/p thr on (b)(6) 2014.All trial hardware was removed and the surgeon started to remove the reamer tip from the canal.A separate 3 inch incision over the lateral aspect of distal femur, multiple drill holes and a rectangular cortical window was made; 1.5cm by 3 cm was made with a 1.5cm extension of fracture line distally.The window was opened and the tip was removed.The window was closed using 2 cables to stabilize the window.Right femur x-ray (b)(6) 2015, revealed hip implant in excellent position.The patient's height 5"2", weight (b)(6), x-rays, kidney stones, osteoarthritis, and allergies (adhesive tape, avelox, barley, beer-derived products, biaxin, cortisone, dander, dust mites, grass, levaquin, mold, penicillin, ragweed and sulfa antibiotics) were added to the complaint.

Manufacturer Narrative

(b)(6).Device is an instrument and is not considered implanted.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.

Manufacturer Narrative

Updated additional information device 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 Description

On 6/1/16 complaint re-opened, on 6/7/17 - medical records received from attorney's office.Event description and commodities were updated.On 6/7/17 update: medical records received.The patient completed physical therapy (b)(6) 2014 and will continue independently; all therapy goals met, returning to previous functional status.Medical history: nephrolithiasis, urticaria, dysmetabolic syndrome, hematura, hypercholesterolemia, leukocytopenia, hip osteoarthritis, obesity, chronic pain, unspecified vitamin deficiency, post-operative nausea & vomiting (ponv).This complaint involves 1 device.

• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5522548
• MDR Text Key: 41037811
• Report Number: 2520274-2016-11808
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 108