MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPARE REAMER TUBE FOR HOLLOW REAMER (309.065

Catalog Number	309.068
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: received a complaint of broken hollow reamer cat.No.-309.068 from (b)(6) medical college.The instrument is broken at the cutting edge.Instrument broke intra op.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A review of the device history records has been requested.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 (b)(6), 2018, during an unknown procedure, the spare reamer tube broke at the cutting edge.Fragments were generated from the broken device but were removed easily.Another hollow reamer used to complete the procedure.There was a 2-hour surgical delay.Procedure was completed successfully.Patient outcome was unknown.Concomitant medical products: hollow reamer for screws 6.0 to 7.0 mm (part #: 309.065, lot #: 9825481, quantity: 1).This report is for one (1) spare reamer tube for hollow reamer.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history records review was completed for part: 309.068, lot: 9698887.Manufacturing location: bettlach, release to warehouse date: jan 26, 2016.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 criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Furthermore, as indicated in the manufacturing documents the correct material (1.4112) was used and the hardness was with the measurement of 652 hv10, 662 hv10 and 663 hv10 according to specification of a minimum of 620 hv10 and maximum 720 hv10.Product investigation was completed.Upon visual inspection of the complaint device it can be seen that at the proximal end a bit is broken off from the instrument, this thus confirming the complaint description.During investigation, dimensional inspection met specification.The exact reason for this occurrence could not be determined.It can be assumed that during the operation an application error may have taken place or/and that a mechanical overloading situation must have led to the breakage.No product fault could be detected.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.

• Brand Name: SPARE REAMER TUBE FOR HOLLOW REAMER (309.065
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8237873
• Report Number: 8030965-2019-59772
• Device Sequence Number: 13506745
• Product Code: HTO
• UDI-Device Identifier: 07611819201873
• UDI-Public: (01)07611819201873
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/17/2018

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 Catalogue Number: 309.068
• Device Lot Number: 9698887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 01/15/2019; 02/04/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/31/2019; 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1