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

Model Number	357.405
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part # 357.403, synthes lot # us91162, supplier lot # us91162, release to warehouse date: 03 jun 2008, supplier: orchid unique, no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the 6.0 mm/ 10.0 mm step drill bit cannulated, large qc, tfn (part # 357.403, lot # us91162, mfg # 03- jun-2008) was received at us customer quality (cq) with no visual defects.There was no sign of a proximal bend.Functional test: a functional test was performed, and the drill stop attached to the proximal end of the step drill bit was unable to be disassembled.The complaint was able to be replicated, therefore the complaint is confirmed.The cutting portion of the reamer is dull to the touch and worn.The complaint of the reamer not being able to fit in the motor could not be confirmed since the motor was not returned.Dimensional inspection: dimensional analysis was within specification based on drawing.Document/specification review: the following drawing(s) was reviewed; 6.0 mm/ 10.0 mm step drill bit cannulated, large qc, tfn.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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, reports an event in (b)(6) as follows: it was reported that on an unknown date, the stepped drill bit in question doesn't fit in the motor since the proximal part is worn out.There is no consequence to the patient.This report is for one (1) drill stop.This is report 2 of 2 for (b)(4).

• 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: 9824817
• Report Number: 2939274-2020-01253
• Device Sequence Number: 13756296
• Product Code: FZX
• UDI-Device Identifier: 10886982196286
• UDI-Public: (01)10886982196286
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: 357.405
• Device Catalogue Number: 357.405
• Device Lot Number: 5638320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1