MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 115MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.308S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: flow: device interaction/functional.Visual inspection: the helical blade (part # 456.308, lot # 5483342, mfg # 15-may-2007) was received at us cq with the blade discolored and faded.The device is also scratched which is consistent with implantation and explantation.Functional test: a functional test was performed, and the helical blade/screw extractor distal tip could not be disassembled from the helical blade.This is consistent with the reported complaint condition; the complaint was able to be replicated; therefore, the complaint is confirmed.Dimensional inspection: dimensional analysis was not performed as relevant features are inaccessible due to the distal tip of the screw extractor being lodged within the screw.Conclusion: 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 unintended forces.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part number: 456.308s, lot number: 5483342, part manufacture date: may 15, 2007, manufacturing location: (b)(4), part expiration date: apr 30, 2016, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 11.0mm ti helical blade 115mm-sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The review of the raw material device history record revealed one rework associated with bp82 raw material lot 5192519.The rework consisted of verifying the first and last piece for alloy type and lot no.And marking all 4680 pieces with alloy type and lot.Since all 4680 pieces of part number 21012, lot 5192519 were accepted without any nonconformities noted, the rework of raw material lot 5192519 is not relevant to this complaint.This raw material 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.Device history review: this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to 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.
Event or Problem Description
It was reported that on an unknown date, during a routine incoming inspection of a loaner set, it was observed that a helical blade/screw extractor and a helical blade were stuck together.There was no known patient or hospital involvement.This is 2 of 2 for report (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 115MM-STERILE
• 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: 9812361
• Report Number: 2939274-2020-01194
• Device Sequence Number: 18993500
• Product Code: HSB
• UDI-Device Identifier: 10886982226785
• UDI-Public: (01)10886982226785
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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 Expiration Date: 04/30/2016
• Device Model Number: 456.308S
• Device Catalogue Number: 456.308S
• Device Lot Number: 5483342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/10/2020
• Patient Sequence Number: 1