MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM UNIVERSAL DRILL GUIDE

Model Number	323.36
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: service & repair evaluation: the customer reported that 3.5 mm lc-dcp drill guide neutral and load spring laded ball came off during regular cleaning process.In addition, the 3.5 mm universal drill guide: defective spring-loaded end makes the entire universal drill guide defective.No patient involvement.This complaint involves (2) devices.The repair technician reported that the tip off drill sleeve is broken.Tip broken is the reason for repair.The cause of the issue is unknown.The following parts were replaced drill sleeve, 3.5mm universal drill guide.The item was repaired per the inspection sheet, passed synthes final inspection on 22-aug-2019 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.Device history lot: part: 323.360, lot: 8402591, manufacturing site: hägendorf, release to warehouse date: may 24, 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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
Device report from synthes reports an event in (b)(6) as follows: 3.5 mm lc-dcp drill guide neutral and load spring laded ball came off during regular cleaning process.In addition, the 3.5 mm universal drill guide: defective spring-loaded end makes the entire universal drill guide defective.No patient involvement.This is report for 01 of 01 of (b)(4).

• Brand Name: 3.5MM UNIVERSAL DRILL GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9203982
• Report Number: 2939274-2019-61631
• Device Sequence Number: 2639397
• Product Code: FZX
• UDI-Device Identifier: 10886982190826
• UDI-Public: (01)10886982190826
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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: 323.36
• Device Catalogue Number: 323.36
• Device Lot Number: 8402591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1