MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRILL STOP; GUIDE

Catalog Number	357.405
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement was 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)(6).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.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 (b)(4) reports an event in (b)(6) as follows: it was reported the drill stop connection screw does not hold the wick.This issue causes inaccurate measurements.Scratches were also noted on the drill bit and sleeve of the connection device.No patient or surgery involvement was reported.This report is for one (1) drill stop this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Part: 357.405; synthes lot: 6722819; supplier lot: n/a; release to warehouse date: september 19, 2011; expiration date: n/a; supplier: 3-d medical machining, inc.; no nonconformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The following investigation flow was performed: device interaction/functional.Visual inspection performed at customer quality (cq) confirmed the condition of scratches, which agrees with the reported complaint condition.Functional test performed at customer quality (cq) confirmed the condition of the drill stop slipping on the drill bit, which agrees with the reported complaint condition.The returned drill stop was manufactured in september 2011 and is over 6 years old.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The complaint is due to the returned drill stop having been manufactured prior to a design change.A review of the current design drawing and the drawing revision at the time of manufacture was performed.The design history was found to impact the complaint condition.These changes improved the overall engagement of the drill stop plunger mechanism with the grooves of the stepped drill bit.During the investigation, no discrepancies were observed and the current design was determined to be suitable for the intended use when employed and maintained as recommended.Therefore, from a design perspective this complaint is valid but has been adequately addressed.The complaint is confirmed, was able to be replicated, and is due to the returned drill stop having been manufactured prior to a design change as well as the returned drill bit also having been manufactured prior to design change.A corrective and/or preventative action is already launched.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.
Additional Manufacturer Narrative
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.

• Brand Name: DRILL STOP
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7362840
• Report Number: 2939274-2018-51177
• Device Sequence Number: 1426689
• Product Code: FZX
• UDI-Device Identifier: 10886982196286
• UDI-Public: (01)10886982196286(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2018

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: 357.405
• Device Lot Number: 6722819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 05/31/2018; 06/22/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 06/07/2018; 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1