MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0MM DRILL GUIDE; BIT,DRILL

Catalog Number	387.20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2018 spine consultant notified customer service that the central processing staff alerted him that the drill guide (387.2) was broken.The sales consultant reported that the set (105.897-e, cslp, fe108121) was not used since the case was cancelled.No patient or procedure involvement.This complaint involves one part.This report is 1 of 1 for (b)(4).

• Brand Name: 3.0MM DRILL GUIDE
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7443785
• Report Number: 2939274-2018-51826
• Device Sequence Number: 19119423
• Product Code: HTW
• UDI-Device Identifier: 10705034770895
• UDI-Public: (01)10705034770895
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Type of Report: Initial
• Report Date (Section B): 04/02/2018

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: 387.20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1