MAUDE Adverse Event Report: SYNTHES BETTLACH REAMER Ø11 F/PFNA BLADE

Catalog Number 356.821

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight not reported.(b)(4).Part of device remains in the patient; device not considered implanted/explanted during the initial procedure on (b)(6) 2016.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.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 Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: while inserting a pfna (proximal femoral nail antirotation) in the femur, on (b)(6) 2016, the reamer tip broke during the reaming process of the bone.The reamer tip was left inside of the bone head and was unable to be retrieved.The surgeon proceeded to insert the nail, although the reaming process was not able to be completed.When the surgeon inserted a pfna long nail, he forcibly hammered the long nail and subsequently a guide pin for the proximal blade interfered with the nail.It was noted no instruments appeared loosened due to the manual hammering.A surgical delay of 10 minutes was reported.Patient status is unknown.Concomitant device: unknown blade (part/lot unknown, qty 1) unknown nail (part/lot unknown, qty 1) this is report 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(6).Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: september 15, 2004.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.A product investigation was completed: the visual incoming inspection showed that the reamer tip is broken.Fragments which are broken off were not sent back as they remained inside of the bone head like reported.Cutting flutes, shaft section including laser inscription and drive section of this reamer do show normal wear signs.Device history record review showed that this reamer was manufactured by supplier sphinx ag in the year 2004.Hardening of the raw material was checked and did conform to the set tolerance range.No deviation of manufacturing documents could be found.The complaint could be confirmed as tip section is indeed broken like reported.Nevertheless no manufacturing related failure could be found.It is likely based on the wear signs detected and the manufacturing year of 2004 that this reamer was often used and this issue is due to wear and tear over time.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.

Event Description

Concomitant device: blade (possible part 456.Xxx, lot unknown, quantity 1), nail (possible part 472.Xxx or 473.Xxx, lot unknown, quantity 1).

• Brand Name: REAMER Ø11 F/PFNA BLADE
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6221603
• MDR Text Key: 63835342
• Report Number: 2520274-2017-10016
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.821
• Device Lot Number: 2109045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN BLADE (PART/LOT UNKNOWN, QTY 1); UNKNOWN NAIL (PART/LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR