MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISSPLANT STRAIGHT DRILL 4.2MMD SHORT PRODUCT CODE SPD4.2S; POWERED BONE DRILL

Model Number	SPD4.2S
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4) distributor found during incoming inspection, a lack of groovings and laser markings in order to show 6mm and 13mm depth on our (b)(4) powered bone drill.Distributor received the correct part, however they received the previous revision of this drill which is now marketed with the new groovings and laser markings.Distributor requested replacements with the newest revisions.
Additional Manufacturer Narrative
Part: spd4.2s revision: p visual: drill was received in vial with seal intact.Specification should be: length: 31mm ±.0.25mm specification as found: n/a diameter: 4.20mm +0.0 /-0.03mm specification as found: n/a comments: customer stated "in our incoming inspection, we found lack of the groove and laser marking in order to show 6 mm depth on spd4.2s" after visual inspection i found that the drill meets all specifications for revision p.There was a revision change released on 03/04/2015 before this order was placed.Revision "q" now indicates where the groove and laser marking area will be located.Drills are acceptable in its current state as this lot was manufactured prior to the release of the new revision.Did not open the vial, performed a visual inspection only.Date of inspection: (b)(4) /2018.
Event or Problem Description
(b)(4) distributor found during incoming inspection, a lack of groovings and laser markings in order to show 6mm and 13mm depth on our spd4.2s powered bone drill.Distributor received the correct part, however they received the previous revision of this drill which is now marketed with the new groovings and laser markings.Distributor requested replacements with the newest revisions.

• Brand Name: SWISSPLANT STRAIGHT DRILL 4.2MMD SHORT PRODUCT CODE SPD4.2S
• Common Device Name: POWERED BONE DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7326752
• Report Number: 3001617766-2018-00038
• Device Sequence Number: 10981683
• Product Code: DZI
• UDI-Device Identifier: 10841307117476
• UDI-Public: 10841307117476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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: Dentist
• Device Model Number: SPD4.2S
• Device Catalogue Number: SPD4.2S
• Device Lot Number: 72432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1