MAUDE Adverse Event Report: SYNTHES BRANDYWINE 11.0MM/3.2MM WIRE GUIDE 222MM

Catalog Number	357.381
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.A device history record review will be requested for the subject device lot.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 during an initial surgery to treat a hip fracture with trochanteric fixation nail (tfn) implants on (b)(6) 2017, the wire guide would not go through the blade guide sleeve all the way and the helical blade inserter is stuck inside of the blade guide sleeve.While assembling the triple trocar assembly which consisted of the blade guide sleeve, wire guide, trocar, and buttress/compression nut, at the back table, the surgical technician noticed that the wire guide would only go half way in the blade guide sleeve.Upon inspecting the outside of the blade guide sleeve, it appears that it has taken a couple of hits by a mallet in the past.A backup trochanteric fixation nail advanced (tfna) set was available however, surgeon decided to move ahead with the case using the two devices to prevent any surgical delays.The devices were successfully used with the aiming arm (concomitant) and insertion handle (concomitant).When removing the wire guide and blade guide sleeve during surgery, the wire guide was jammed in the blade guide sleeve.A two to three seconds surgical delay was noted due to removing the devices using a pair of pliers.After the helical blade was successfully inserted using the helical blade inserter, helical blade coupling screw (concomitant), and blade guide sleeve (same device as early on), it was found that the helical blade inserter was stuck in the blade guide sleeve.The helical blade coupling screw was easily removed from the assembly.The procedure was successfully completed with a two to three seconds surgical delay.No other medical intervention was required.The patient status/outcome was reported as stable.After surgery, the two devices remain stuck together however, it is unknown if sterile processing was able to detach them.Concomitant devices reported: mallet (part # unknown, lot # unknown, quantity of 1), 3.2mm trocar (part # 357.383, lot # unknown, quantity of 1), buttress/compression nut (part # 357.371, lot # unknown, quantity of 1), 130 degree aiming arm (part # 357.366, lot # unknown, quantity of 1) , insertion handle (part # 357.411, lot # unknown, quantity of 1), 11.0mm helical blade (part # 456.303, lot # unknown, quantity of 1), helical blade coupling screw (part # 357.377, lot # unknown, quantity of 1) and pliers (part # unknown, lot # unknown, quantity of 1).This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Lot numbers added for concomitant devices: 3.2mm trocar, buttress/compression nut, 130 degree aiming arm, insertion handle and helical blade coupling screw.A device history record (dhr) review for part # 357.381 lot # 5034433: release to warehouse date: (b)(6) 2005, expiration date: na, manufactured by (b)(4): no non conformance reports (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.A product development investigation was performed.The following parts were reported with malfunctions: blade/guide sleeve: 357.369, lot 5046640-stuck to inserter, helical blade inserter: 357.372, lot unknown-stuck to blade/guide sleeve, wire guide: 357.381, lot 5034433-does not fit with blade/guide sleeve ¿ unconfirmed, trocar: 357.383, lot 5015916-bent.The complaint condition was able to be confirmed for all but the wire guide.The wire guide was functionally tested with a known good blade/guide sleeve and was able to slide in and out as intended.The device interaction issue is likely isolated to just the complained blade guide sleeve as the reporter stated that it appeared to have been hammered upon.A visual inspection, functional test, device history records review, and drawing review were performed as part of this investigation.The following part(s) was returned as a concomitant device without an alleged complaint condition.Upon visual inspection there is no evidence that this device contributed to the complaint condition, and therefore no additional investigation will be performed on these devices: buttress compression nut: 357.371, lot 4987427, aiming arm: 357.366, lot 5016997, insertion handle: 357.411, lot 4959070, coupling screw: 357.377, lot 5638309.The returned instruments are routinely used in the titanium trochanteric fixation nail system.The blade/guide sleeve was returned with several impact marks along the smooth shaft and the threaded portions.Although the definitive root cause could not be determined with the provided information, it is likely the deformation of the blade/guide sleeve due to previous hammering of the shaft contributed to the complaint condition of will not fit to the wire guide and the jamming of the inserter.The trocar was slightly bent near the center of the shaft.It is uncertain if this happened intraoperatively, sterilization, or transport therefore a root cause could not be determined.Relevant drawings for the returned instrument were examined.During the investigation no product design issues or discrepancies were observed that may have contributed 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.
Event or Problem Description
Concomitant devices reported: mallet (part # unknown, lot # unknown, quantity of 1), 3.2mm trocar (part # 357.383, lot # 5015916, quantity of 1), buttress/compression nut (part # 357.371, lot # 4987427, quantity of 1), 130 degree aiming arm (part # 357.366, lot # 5016997, quantity of 1) , insertion handle (part # 357.411, lot # 4959070, quantity of 1), 11.0mm helical blade (part # 456.303, lot # unknown, quantity of 1), helical blade coupling screw (part # 357.377, lot # 5638309, quantity of 1) and pliers (part # unknown, lot # unknown, quantity of 1).

• Brand Name: 11.0MM/3.2MM WIRE GUIDE 222MM
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6532473
• Report Number: 3003875359-2017-10206
• Device Sequence Number: 1642382
• Product Code: FZX
• UDI-Device Identifier: 10886982196101
• UDI-Public: (01)10886982196101(10)5034433
• 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
• Report Date (Section B): 04/04/2017

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: 357.381
• Device Lot Number: 5034433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2017
• Supplement Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 357.366, 130 DEGREE AIMING ARM, QTY. 1; 357.371, BUTTRESS/COMPRESSION NUT, QTY. 1; 357.377, HELICAL BLADE COUPLING SCREW, QTY. 1; 357.383, 3.2MM TROCAR, QTY. 1; 357.411, INSERTION HANDLE, QTY. 1; 456.303, 11.0MM HELICAL BLADE, QTY. 1; UNKNOWN PLIERS, QTY. 1