MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT 11 F/PFNA BLADE; DRILL, BIT

Catalog Number 356.822

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: an drill bit 11 was returned to depuy synthes for evaluation.Depuy synthes conducted a visual inspection of the returned device.The visual inspection has shown that the tip especially the blades of the drill bit ø11 are completely worn/dull as well as signs of marks and scratches visible.The instrument is in an used condition.The reported "lines" of the surface at the blades, that are part of the cutting geometry as per design intended.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, material and visual criteria at the time of release with no issues documented during the manufacturing process.No nc's were generated during the production of the lot in question.As part of depuy synthes¿ quality process all devices are manufactured, inspected, and released to approved specifications.The received condition agree with the complaint description and the complaint therefore is confirmed.The visual inspection has shown that the tip especially the blades of the drill bit ø11 are completely worn/dull as well as signs of marks and scratches visible.The instrument is in an used condition.The reported "lines" of the surface at the blades, that are part of the cutting geometry as per design intended.After a visual inspection per guidance provided in windchill document, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.End of life definition per important information leaflet, limits on reprocessing: end of life of a device is normally determined by wear and damage due to use.Evidence of damage and wear on a device may include but is not limited to corrosion (i.E.Rust, pitting), discoloration, excessive scratches, flaking, wear and cracks.Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used.No manufacturing related issue was identified and/or confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is appropriate.Device history lot: part: 356.822, lot: u147177, manufacturing site: (b)(4), supplier:(b)(4), release to warehouse date: feb.09, 2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2021 that the patient underwent for a surgery.Before the surgery, it was confirmed that there were some lines on the surface of the drill bit.The surgery was completed with another drill bit.The patient outcome was stable.This complaint involves two (2) devices.This report is for (1) unk - plates.This report is 1 of 1 for (b)(4).

• Brand Name: DRILL BIT 11 F/PFNA BLADE
• Type of Device: DRILL, BIT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11417467
• MDR Text Key: 280447673
• Report Number: 8030965-2021-01638
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 02/19/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 356.822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/04/2021
• Patient Sequence Number: 1