MAUDE Adverse Event Report: SYNTHES HAGENDORF HAMMER GUIDE

Catalog Number	357.071
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was attempted.The report indicates that the: 357.071 / 1034176.Dhr not available as device is older than 17 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to the filing and archiving of specification documents), which was in place till august 2014.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 on an event in (b)(6) as follows: it was reported that the threaded part at tip of the hammer guide broke of intraoperatively.There was a surgery prolongation of 30 minutes.No information about patient outcome.There was no patient harm and the procedure was successfully completed.Fragments were generated but were removed from the patient.This complaint involves 1 part.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.The investigation summary indicates that the: received condition: the hammer guide was received with the m8 connection threaded portion broken off on the tip.The broken off portion is available.The device shows marks and severe wear of often use.Conclusion: the fracture faces are homogenous and show the typical patterns of a forced rupture.The device shows marks and severe wear of often use.In fact, the device was produced and released to warehouse in june 1999.A dhr is not available as device is older than 18 years.During this time, the manufacturing documents for instruments had to be stored for 10 years.This was according to filing and archiving of specification documents) version (b)(4), which was in place till august 2014.Based on the signs of wear and aging as well as the age of the hammer guide, a dimensional check and hardness test was not conducted.A definitive root cause for the breakage cannot be determined.However, the complaint condition was most likely caused by cumulative wear and mechanical overloading over the 18 years¿ life span of the device.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.A definitive root cause for the breakage cannot be determined.However, the complaint condition was most likely caused by cumulative wear and mechanical overloading over the 18 years life span of the device.No manufacturing related issue was identified and/or 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: HAMMER GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6991547
• Report Number: 3003875359-2017-10540
• Device Sequence Number: 497405
• Product Code: FZX
• UDI-Device Identifier: 07611819073609
• UDI-Public: (01)07611819073609(10)1034176
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2017

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: 357.071
• Device Lot Number: 1034176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1