MAUDE Adverse Event Report: SYNTHES HAGENDORF SPIRAL BLADE INSERTER F/EXPERT HAN; GUIDE

Catalog Number	03.008.011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.Date returned to manufacturer.Facility phone number: (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 conducted.The report indicates that the: part #03.008.011 / lot # 3753480, manufacturing location: (b)(4), manufacturing date: 13.April 2011.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device history records review was attempted/ dhr review request: the report indicates that the: 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 spiral blade inserter was found broken at the loan set.The t-shape end of the inserter is loose.The instrument did not broke at the loan department.No patient involvement.The part has a broken pin and has a very used condition.This complaint involves 1 part.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: a product investigation was completed: we have received the article 03.008.011 spiral blade inserter for investigation.The condition of the inserter can be described as worn.The device shows significant use during its six (6) year of lifespan.All over the device are deep impression marks and scratches visible.The cutting edges of the spiral blade are worn out and additionally are some significant hammering marks at the bottom of the t-part visible.The dowel pin which holds the t-part is broken and the housing spring is missing.The device history record was researched and no abnormal findings were identified.Based on the provided information we are not able to determine the exact cause of this complaint.It is likely that the dowel pin broke due to intense hammering and consequently the reason was for the loosening of the t-part.Per the product literature, 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.Based on the provided information we are not able to determine the exact cause of this complaint.It is likely that the dowel pin broke due to intense hammering and consequently the reason was for the loosening of the t-part.No indication for product related issue was found.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: SPIRAL BLADE INSERTER F/EXPERT HAN
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6273723
• Report Number: 3003875359-2017-10037
• Device Sequence Number: 89315
• Product Code: FZX
• UDI-Device Identifier: 07611819331099
• UDI-Public: (01)07611819331099(10)3753480
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2017

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: 03.008.011
• Device Lot Number: 3753480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2017
• Supplement Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1