MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5 DIA DB 6 STOP 13 LNTH 90 SCRDRIVER; DRILL, BONE, POWERED

Model Number	03.505.041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-code: dzj.Without a valid lot number the device history records review could not be completed.Complainant device is not expected to be returned for manufacturer review/investigation.Occupation: initial reporter is j&j company representative.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 on an unknown date, there was a drill bit and 2.0mm titanium matrix mandible screw that was broken.A broken drill bit was a 1.5 drill bit for the 90-degree screwdriver self-tapping mandible and the screw with 2.0 screw 8mm length and the drill bit was a drill bit and the screwdriver broke for this adverse event.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.  this complaint involves two (2) devices.This report is 1 of 1 for (b)(4).

• Brand Name: 1.5 DIA DB 6 STOP 13 LNTH 90 SCRDRIVER
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11962763
• Report Number: 2939274-2021-02843
• Device Sequence Number: 17035476
• Product Code: DZI
• UDI-Device Identifier: 10887587013497
• UDI-Public: (01)10887587013497
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K082649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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 Model Number: 03.505.041
• Device Catalogue Number: 03.505.041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1