MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIM-ARM F/EXPERT R/AFN RETROGR F/SPIRAL; GUIDE

Catalog Number	03.010.051
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.It is unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.Reporter¿s phone number is unknown.A device history record (dhr) review was conducted for part # 03.010.051, synthes lot # 1814506: manufacturing site: (b)(4), release to warehouse date: 19.Mar.2008: the device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was conducted.At customer quality, the returned aiming arm (part # 03.010.051, lot # 1814506, mfg # 19-mar-2008), spiral blade inserter (part: 03.010.084, lot: 1818414, mfg: 08-feb-2008) was received at us cq.Visual inspection: the aiming arm (part # 03.010.051, lot # 1814506, mfg # 19-mar-2008) was inspected at us cq.The aiming arm and spiral blade inserter were received stuck together and could not be separated.The inserter could not be advanced or retracted from the received position in the aiming arm.The aiming arm shows signs of minimal wear and it has corrosion stains on the etched region.The received condition agrees with the complaint description.Dimensional inspection: dimensional analysis was not performed as an accurate measurement of the relevant feature (diameter of the hole were the spiral blade inserter is inserted) cannot be measured accurately as the aiming arm was not able to be disassembled from the spiral blade inserter.Document/specification review: relevant drawing(s) was reviewed; no design or manufacturing defect or deficiency was observed during the investigation.Investigation conclusion: the complaint condition is confirmed.While no definitive root cause could be determined for the complaint condition, it is possible that the device encountered unintended forces during its lifetime (10 years).The definitive root cause for the rust on the etched region could not be determined, but it might be because of the exposure to liquids during the decontamination process.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 an unknown date, devices were experiencing issues either broken or not performing as they should.A depth gauge broke, and a spiral blade inserter was stuck in the aiming arm.All device malfunctions were found in the sterile processing department.There was no patient and procedure involved.Upon receipt of the device it was identified that the inserter could not be advanced or retracted from the received position in the aiming arm.The aiming arm shows signs of minimal wear and it has corrosion stains on the etched region.This condition was re-evaluated and determined to be reportable on (b)(6) 2018.This report is for one (1) aim-arm f/expert r/afn retrogr f/spiral.This is report 2 of 3 for complaint (b)(4).

• Brand Name: AIM-ARM F/EXPERT R/AFN RETROGR F/SPIRAL
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7739586
• Report Number: 2939274-2018-53156
• Device Sequence Number: 11031996
• Product Code: FZX
• UDI-Device Identifier: 10886982067234
• UDI-Public: (01)10886982067234
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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 Catalogue Number: 03.010.051
• Device Lot Number: 1814506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1