MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPIRAL BLADE AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.055
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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 europe reports an event in (b)(6) as follows: it was reported that the case was done on (b)(6) 2017 and there was an issue with drill sleeves jamming.The surgeon inserted a short nail, spiral blade and screw in the proximal locking hole.During the procedure, the doctor was shaking the jig up and down while it on the nail; the drill sleeves were filled with tissue and got jammed.The doctor was using the 3.2 drill sleeves for distal locking, he went to remove the trocar and it was very tight and did not want to come out.The drill sleeve and trocar was stuck together.When they were able to get the trocar combination drill sleeves out, there was a lot of tissue in the tip.It was cleaned with peroxide to release the tissue they were taken out and washed.He then continued to put the screw in without checking under image.The screws missed the nail and were removed.Everything was taken out, cleaned and reinserted.All screws were able to be inserted correctly thereafter.The drill sleeves and the locking jig were checked after the procedure and lined up correctly.Concomitant devices: spiral blade (part 462.646, lot unknown, quantity 1); guide wire (part 292.260, lot unknown, quantity 1); k-wire (part 03.010.025, lot unknown, quantity 1); drill bit (part 03.010.060, lot unknown, quantity 1); proximal humeral nail (part 04.001.410s, lot 9837059, quantity 1).This report is for 3 unknown locking screws.(b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A product evaluation was performed for the subject device as follows: complained issue could not be replicated and/or confirmed based on the available information (incl.Pictures and/or x-ray¿s).A functionality test was done on the item internally by cls.All parts were tested and the results comply.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Unfortunately, we are not able to determine the exact reason for this occurrence, but we have to reasonably conclude that during the operation an application error may have taken place.To prevent such problems, it is necessary to operate according to the technique guide.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Additional narrative: mfr site.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 AIMING ARM FOR TI CANNULATED HUMERAL NAILS-EX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7286216
• Report Number: 8030965-2018-51283
• Device Sequence Number: 1475341
• Product Code: LXH
• UDI-Device Identifier: 07611819796416
• UDI-Public: (01)07611819796416(10)LOTUNKNOWN
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2017

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: 03.010.055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: 02/27/2018; 02/28/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 02/27/2018; 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1