MAUDE Adverse Event Report: SYNTHES HAGENDORF PERIARTICULAR AIMING ARM FOR 4.5MM LCP CURVD CONDYLAR PL-LT; GUIDE

Catalog Number	03.120.011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history records review was completed for part# 03.120.011, lot# 1810703.Manufacturing location: (b)(4), manufacturing date: feb 12, 2008.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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 or Problem Description
It was report that the patient had original surgery on (b)(6) 2017 for treatment of a poly-trauma to the right femur bone due to a (mva) motor vehicle accident.Patient was implanted with a one (1) 12mm lateral entry femoral reconstruction expert (ex) nail, two (2) 6.5mm reconstruction screws and one (1) 5.0mm locking screw to treat the patient's broken medshaft fracture.Patient was also implanted with one (1) 4.5mm locking compression plate (lcp) curved condylar plate, with a unknown quantity of various lengths of cannulated locking screws to address the patients distal femur fracture.During the procedure, while the surgeon was implanting the lateral entry femoral nail, while he was drilling through the nail and rotating the insertion handle, the alignment metal tab to the insertion handle broke off.Additional images were taken to locate this 2mm by 3mm in size fragment, but it could not be located.Surgeons chose another insertion handle that was available in the operating room to complete the surgery.Due to this event an additional 15-minute delay was added to operating room time.Surgeon completed the nail insertion and continued with the distal compression plate and screws portion of the procedure.During the plate and screw insertion segment of the procedure, as the surgeon was tightening down with the aiming arm instrument to connect the condylar plate, the bolt that is a component of the aiming arm instrument sheared off and landed on the operating room floor.This bolt is 20mm in size and was easily retrieved.Surgeon disconnected the aiming arm instrument and continued the procedure by using a standard drill guide that was available in the operating room.Due to this event an additional 10-minute delay was added to operating room time.Surgery was completed successfully with a 25-minute total time delay due to both events.The patient was reported in stable condition.Concomitant devices reported: 12mm ti lateral entry femoral reconstruction nail ex400mm/right sterile (part# 04.003.560s, lot# unknown, quantity 1); 6.5mm ti reconstruction screw with t25 stardrive 105mm-sterile (part # 04.003.031s, lot# unknown, quantity 1); 6.5mm ti reconstruction screw with t25 stardrive 100mm-sterile (part# 04.003.030s, lot# unknown, quantity 1); 5.0mm ti locking screw w/t25 stardrive 44mm for nails (part# 04.005.534s, lot# unknown, quantity 1); 4.5mm lcp curved condylar plate 16h/350mm left sterile (part# 02.001.306s, lot# unknown, quantity 1); 7.3mm cannulated locking screw (part# unknown, lot # unknown, quantity unknown, various screw lengths).This report is for one (1) periarticular aiming arm for 4.5mm lcp curvd condylar pl-lt.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: customer quality investigation of returned devices: a visual inspection , dhr review, and drawing review were performed as part of this investigation.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned devices are already missing components.The 03.120.011, lot number 1810703, periarticular aiming arm for 4.5mm lcp curvd condylar pl-lt was returned with a missing coupling bolt.This complaint is confirmed.The bolt was not returned with the instrument.The coupling bolt sheared off from the 8mm pin.Although a definitive root cause could not be determined, it is likely that this complaint condition was due to consistent/excessive force being applied to the bolt over the part¿s lifetime (9+ years) leading to the breakage.The 03.010.045, lot number 1627067, standard insertion handle was returned with the tang (alignment tab) broken off.This complaint is confirmed.Although a definitive root cause could not be determined, it is likely that this complaint condition was due to excessive bending forces when the surgeon was "rotating the insertion handle" causing material fatigue and breakage of the tang.This complaint condition is consistent with constant usage over the part¿s lifetime (10+ years).Drawing mfg to current were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.A design change to improve the strength of tang was implemented.This design change is related to this complaint condition and can possibly help prevent future similar complaints.The design and clinical risk management (dcrm) document was reviewed and found to adequately address the harm of this complaint condition 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.

• Brand Name: PERIARTICULAR AIMING ARM FOR 4.5MM LCP CURVD CONDYLAR PL-LT
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6714530
• Report Number: 3003875359-2017-10340
• Device Sequence Number: 531364
• Product Code: FZX
• UDI-Device Identifier: 10886982074096
• UDI-Public: (01)10886982074096(10)1810703
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 03.120.011
• Device Lot Number: 1810703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1