MAUDE Adverse Event Report: SYNTHES HAGENDORF DEPTH PROBE FOR MULTILOCHUMERAL NAILING SYSTEM

Catalog Number	03.019.029
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.It is unknown when the instrument was broken and it was reportedly discovered to be broken on (b)(6) 2015.(b)(4).Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation.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.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
Synthes (b)(4) reported events in (b)(6) as follows: it was reported that the tip of the depth gauge was found to be broken during instrument inspection on (b)(6) 2015.This instrument is part of a synthes multiloc humeral nailing system loan set and the depth gauge was discovered to be broken before it was delivered to the hospital.There was no report of prior patient or surgical involvement.It is unknown when the depth gauge was broken.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Manufacturing location: (b)(4).Manufacturing date: august 09, 2013.No non-conformance reports 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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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
Manufacturing investigation evaluation: one (1) length probe for multiloc humeral nailing system (part 03.019.029) was received for manufacturing investigation.The instrument has a broken off wire for measuring head.According to the manufacturing investigation, there is no indication of a production failure that could be found.The inner and outer diameter of the welded connection, and the other inspected measurements, met specifications.Several damages on the measuring instrument were observed during the investigation.For example, the surface around the laser welding was deformed.This deformation weakened the strength of the laser welding, which likely led to the breakage.Based upon the information provided, it is most likely that the surface damages happened post-production.Therefore, mishandling cannot be excluded.No manufacturing related issues were 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: DEPTH PROBE FOR MULTILOCHUMERAL NAILING SYSTEM
• Common Device Name: PROBE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• MDR Report Key: 5364940
• Report Number: 2520274-2016-10211
• Device Sequence Number: 32642
• Product Code: HXB
• UDI-Device Identifier: 07611819462311
• UDI-Public: (01)07611819462311(10)8532062
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PEXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date (Section B): 12/24/2015

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: 03.019.029
• Device Lot Number: 8532062
• Other Device ID Number: (01)07611819462311(10)8532062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/08/2016; 02/08/2016
• Initial Report FDA Received Date: 01/13/2016
• Supplement Report FDA Received Date: 02/02/2016; 02/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1