MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 6.0MM CARBIDE DRILL BIT STERILE; BIT, DRILL

Model Number	309.006S
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: hwe.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) 2020, the patient underwent a revision surgery for the femur for an unknown reason.During the revision, when the surgeon opened the package of the drill bit, it was discovered intraoperatively, that white power had adhered to the carbide drill bit.The surgery was completed by using another carbide drill bit.It is unknown if there was surgical delay.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: picture review: narrative (white residues on the drill bit) could be confirmed from provided picture.H3, h6: a product investigation was conducted.Visual inspection: the visual investigation of the complained carbide drill bit shows that there are some very small white residues visible on the surface which can be identified as from the blister package.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Document/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no document/specification review is needed.Summary: the visual inspection of the returned part has shown that there are some white residues visible on the surface of the packaging which can be identified as from the blister package.This lot of 100 pieces was manufactured in december 2009 according to the specification.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.These residues are a result of rubbing of the part at the blister during transport.This is caused by many transports as result of the loan business.The carbide drill bit was slightly moving, and shaving off the inside surface of the package, in its more than 10 years of live span.This material is bio compatible and no risk about this.It can also be stated that these particles are sterile as well.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h4, h6: a device history record (dhr) review was conducted: part: 309.006s, lot: 2545048, manufacturing site: bettlach, release to warehouse date: 01 dec 2009, expiry date: 01 nov 2019.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.

• Brand Name: 6.0MM CARBIDE DRILL BIT STERILE
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10250073
• Report Number: 8030965-2020-04730
• Device Sequence Number: 10935070
• Product Code: HTW
• UDI-Device Identifier: 10886982185532
• UDI-Public: (01)10886982185532
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2020

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 Expiration Date: 11/01/2019
• Device Model Number: 309.006S
• Device Catalogue Number: 309.006S
• Device Lot Number: 2545048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 07/30/2020; 08/21/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/18/2020; 08/28/2020
• Patient Sequence Number: 1