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

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 02/07/2018

Event Type  malfunction  

Event 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.

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 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
• Type of Device: POWERED BONE DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: crystal barczi ; 3050 e hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7326752
• MDR Text Key: 102219170
• Report Number: 3001617766-2018-00038
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10841307117476
• UDI-Public: 10841307117476
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 02/15/2018
• Supplement Dates FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1