MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM TI CANNULATED HUMERAL NAIL-EX/240MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.001.428S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 reported that on (b)(6) 2019, patient underwent removal of titanium cannulated humeral nail ex, titanium locking screw 30 mm and titanium locking screw 38 mm.Implants were removed due to humeral shaft non-union.The patient originally had the humeral nail construct implanted to treat his humerus fracture on an unknown date.Patient was revised to a 9 hole 4.5 mm lcp broad plate and eight (8) 4.5 mm cortex screws.The surgery was successfully completed without delay.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Visual inspection: 9mm ti cannulated humeral nail-ex/240mm-sterile was received at cq.Upon visual inspection, it is observed that the device shows some discoloration, scratches, and deformation which may have occurred during explantation.No device problem was found.Mre review: this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Investigation conclusion: visual inspection, and document specification review of the received device was performed at cq.The complaint condition cannot be confirmed with the information available.A definitive root cause could not be determined.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Manufacturing location: monument manufacturing date: 26-may-2017, expiration date: 30-apr-2026, part number: 04.001.428s, 9mm ti cannulated humeral nail-ex/240mm-sterile, lot number: h374525 (sterile), lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance, 4001ipa218 rev e met all inspection acceptance criteria.Inspection sheet, inspect dimensional 4001id418, rev f met all inspection acceptance criteria.Inspection sheet, final inspection, 4001fi418, rev d met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev h was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn 13775 supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.

• Brand Name: 9MM TI CANNULATED HUMERAL NAIL-EX/240MM-STERILE
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8671461
• Report Number: 2939274-2019-58488
• Device Sequence Number: 2182842
• Product Code: JDS
• UDI-Device Identifier: 10886982081056
• UDI-Public: (01)10886982081056
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K033071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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 Expiration Date: 04/30/2026
• Device Model Number: 04.001.428S
• Device Catalogue Number: 04.001.428S
• Device Lot Number: H374525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 06/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention