MAUDE Adverse Event Report: SYNTHES BETTLACH HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0MM SCREWS

Catalog Number	309.065
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement reported.Date of device breakage is not known.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Dhr review was completed.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.(b)(4).Manufacturing date: 10.Mar.2004.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 the spare reamer tube and hollow reamer complete for 6.5mm & 7.0 mm screws were discovered broken during routine maintenance inspection in the sterile processing department.This was discovered after sterile processing.This complaint does not involve any patient or procedure.Preliminary review of the returned devices revealed the spare reamer tube has two (2) cracks on the distal end but is not broken.This report is for one (1) hollow reamer.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Customer quality completed an investigation of the returned devices.The following device were returned to cq: part #309.068 lot# spare reamer tube for hollow reamer (309.065); mfg date: 25nov2003 part #309.065 lot# hollow reamer complete for 6.5mm & 7.0mm screws; mfg date: 10mar2004 the instruments were returned assembled as one unit.The device shows the instrument was observed to have two cracks towards the distal tip which may hinder the device from functioning as intended.The balance of the device shows normal wear and tear from use.The complaint is confirmed.No new defects or malfunctions were observed on any of the returned instruments.A visual inspection under 5x magnification, dhr review, and drawing review were performed as part of this investigation.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the instruments are already cracked.The instruments are part of the synthes screw removal set which are utilized to remove imbedded synthes screws.The instruments were returned and it was reported that were discovered broken during routine maintenance inspection in the sterile processing department.Dhr review request no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.A dcrm review and/or occurrence rate calculation must be performed for all complaint parts which resulted in a classification of serious injury that were not generated from a literature article.Therefore, no dcrm calculation will be performed for this complaint no definitive root cause could not be determined as the circumstances surrounding the complaint are unknown, however a possible cause could be rough handling during sterile processing may have led to the 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.
Additional Manufacturer Narrative
Investigation summary/additional information: the instruments were returned assembled as one unit.The device shows the instrument was observed to have two cracks towards the distal tip (for part number 309.068, which is a component of 309.065) which may hinder the device from functioning as intended.The balance of the device shows normal wear and tear from use.The hollow reamer complete showed no cracks or breaks that would prevent the device form functioning as intended.The complaint is confirmed.Device 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: HOLLOW REAMER COMPLETE FOR 6.5MM & 7.0MM SCREWS
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6825785
• Report Number: 9612488-2017-10441
• Device Sequence Number: 461416
• Product Code: HTO
• UDI-Device Identifier: 10886982185570
• UDI-Public: (01)10886982185570(10)2089535
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2017

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: 309.065
• Device Lot Number: 2089535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 10/03/2017; 10/05/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 10/04/2017; 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1