MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM UNIVERSAL DRILL GUIDE

Catalog Number	323.46
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part: 323.46; synthes lot: 5408455; release to warehouse date: january 02, 2007; manufacturing site: synthes (b)(4).No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Service & repair history: no service history review can be performed as part number 323.46 with lot number(s) 5408455 is a lot/batch controlled item.The service history review is unconfirmed.Service & repair evaluation: the customer reported the guide was tight and it was difficult to get the cap off.The repair technician reported the variable side drill sleeve was bent.Bent is the reason for repair.The cause of the issue is unknown.The following parts were replaced: drill sleeve.The item was repaired per the inspection sheet, passed synthes final inspection on october 24, 2018 and will be returned to the customer upon completion of the service and repair process.Service record router completed.Finalized service record will be archived.The evaluation was confirmed.The device was deemed serviceable and 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 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 in the sterile processing department on (b)(6) 2018, it was noticed that a universal drill guide seemed tight and hard to get the cap off.There is no procedure and patient involvement.This report is for a 4.5mm universal drill guide.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM 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: 8046010
• Report Number: 2939274-2018-54879
• Device Sequence Number: 1540033
• Product Code: FZX
• UDI-Device Identifier: 10886982190857
• UDI-Public: (01)10886982190857
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/05/2018

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: 323.46
• Device Lot Number: 5408455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1