MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 90MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.303
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: hwc.Reporter is synthes employee.A device history record (dhr) review was conducted: part number: 456.303, lot number: 6174757.Part manufacturing date: 02 july 2009.Manufacturing site: (b)(4).Part expiration date: n/a.Non-conformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 6174757 of ti helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformance's noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot 5892638 met all specifications with no issues documented that would contribute to this complaint condition.A product investigation was conducted.Visual inspection: 11.0 mm ti helical blade 90 mm was received at cq.Upon visual inspection, it was observed that the device has severe discoloration.There are scratches on the surface of the device.The helix was observed to be stripped and severely deformed might be due to rough handling during explantation.Thus, the complaint is confirmed.Dimensional inspection: dimensional inspection cannot be performed due to post manufacturing damage.Document/ specification review: the relevant drawing(s) was reviewed; no design issues or discrepancies were found during this investigation.Mre review: a review of the raw material device history record(s) determined the raw material lot 5892638 met all specifications with no issues documented that would contribute to this complaint condition.Investigation conclusion: visual inspection, and document/ specification review was performed.It was that the device has severe discoloration.There are scratches on the surface of the device.The helix was observed to be stripped and severely deformed.Thus, the complaint is confirmed.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered rough handling.No new malfunctions were observed during this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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, during a routine incoming inspection of loaner set, the helical blade was observed damaged.There was no known hospital or patient involvement.This report is for one (1) 11.0 mm ti helical blade 90 mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 90MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8724655
• Report Number: 2939274-2019-58814
• Device Sequence Number: 16576609
• Product Code: HSB
• UDI-Device Identifier: 10886982226679
• UDI-Public: (01)10886982226679
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2019

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: Health Professional
• Device Model Number: 456.303
• Device Catalogue Number: 456.303
• Device Lot Number: 6174757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1