MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM UNIVERSAL DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Model Number	323.36
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the universal drill guide was non-functional.The repair technician reported the device was missing the spring and the fixed side drill sleeve had bent.The cause of the issue was damaged component.The reason for repair is bent condition of the part.The item will be scrapped.The item cannot be repaired per the inspection sheet and will be forwarded to customer quality.The evaluation was confirmed.The universal drill guide was missing a component and the sleeve of the drill guide had bent.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/ specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot = > part #: 323.36 , synthes lot #: 4077516, release to warehouse date: 10 mar 2000, manufactured by: (b)(4).No ncr's 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.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, during a routine incoming inspection,it was discovered that the universal drill guide was non-functional.There was no known patient or hospital involvement.This report is for one (1) 3.5mm universal drill guide.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM UNIVERSAL DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12728607
• Report Number: 2939274-2021-06397
• Device Sequence Number: 1467313
• Product Code: FZX
• UDI-Device Identifier: 10886982190826
• UDI-Public: (01)10886982190826
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 10/13/2021

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: 323.36
• Device Catalogue Number: 323.36
• Device Lot Number: 4077516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1